How 'bout that new law suit ladies

The links provided in post above are broken. Here are the corrected links...

Current challenges facing Masimo that could prove damaging to the company's "patient safety" image:

April 17, 2013: Personal Injury class action lawsuit is brought against Masimo & co-plaintiffs.
Looney et al. vs. Moore, Masimo et al. (case # 2:13-cv-00733)
Masimo was charged with Wrongful Death, Patient Negligence, and Product liability for their alleged role in the deaths of 237 infant-subjects, and permanent physical & neurological injuries i.e. blindness and brain damage, suffered among hundreds of additional infant-subjects who survived participation in same clinical trial.
“University of Alabama Study Caused Infant Deaths, Suit Claims”
http://www.law360.com/articles/434006/univ-of-ala-study-caused-infant-deaths-suit-claims
http://dockets.justia.com/docket/alabama/alndce/2:2013cv00733/147528

Oct/Dec, 2013: Masimo receives two “483 Forms’ from the FDA, noting multiple patient safety violations observed at two Masimo corporate facilities (Irvine, CA & Mexicali, Mexico) during FDA inspections. Corrective action required.
http://www.sec.gov/Archives/edgar/data/937556/000093755614000072/masi-20140329x10q.htm

May 2014: Masimo hit with Federal Grand Jury Subpoena over patient-monitoring technology
http://www.fiercemedicaldevices.com/story/masimo-hit-subpoena-over-patient-monitoring-tech/2014-05-09
http://www.sec.gov/Archives/edgar/data/937556/000093755614000078/masi-20140508x8k.htm

Aug 2014: FDA Warning Letter:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm410636.htm

Patient Safety Violations observed at Masimo headquarters in Irvine during FDA inspection (Aug - Oct 2013):
1. Failure to review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications as required by 21 CFR 820.198(c). Specifically, multiple complaints of device failures were not adequately reviewed, evaluated, and investigated.
2. Failure of complaint investigation records to include required information, as required by 21 CFR 820.198(e). Specifically, the records of investigations did not contain required information regarding the nature and details of the complaint.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, including requirements for identifying the action(s) needed to correct nonconforming product and other quality problems
4. Failure to establish and maintain procedures for implementing corrective and preventive action, including investigating the cause of nonconformities relating to product, processes, and quality system

2014: Increasing media coverage of MASI's apparent conflict of pt safety standards (stated vs demonstrated).
8/26/14: "Masimo: Warning Letter Becomes Yet Another Distraction for Management"
http://insidetrade.co/masimo-warning-letter-becomes-yet-another-distraction-for-management/

10/6/14: “Medical Company May Be Falling Short Of Its Patient Safety Ideals”
http://www.npr.org/blogs/health/2014/10/06/353524314/masimo-medical-company-may-be-falling-short-of-its-patient-safety-ideals

10/8/14: “Reported Medical Device Defects May Lead To Personal Injury”
http://www.defectivedrugsandproductsblog.com/2014/10/reported-medical-device-defects-may-lead-to-personal-injury.shtml

10/10/14: "Demand Full Reports of Medical Equipment Malfunctions"
http://forcechange.com/133865/demand-full-reports-of-medical-equipment-malfunctions/

10/16/14: “FDA to Device Maker: Complaints Not Properly Investigated”
http://www.patient-safety-blog.com/fda-to-device-maker-complaints-not-properly-investigated/

Now in appeal, the case brought against Masimo by former employees of the company in 2011 (Case # 8:2011cv00734), Masimo was ordered by a judge earlier this year to pay >$5 million in punitive damages for “knowingly requiring salespeople to sell inaccurate blood monitoring equipment that endangered the safety of patients.”
http://dockets.justia.com/docket/california/cacdce/8:2011cv00734/502048
http://www.businesswire.com/news/home/20140213005546/en/Analyst-Alert-Multi-Million-Dollar-Punitive-Damage-Award#.VJLItD8frIU

In his 41-page Award to plaintiffs, Justice Richard C. Neal made other harsh criticisms of Masimo “leadership” that are concerning, with special regard to patient safety:

1. The arbitrator, Richard C. Neal, noted that “Masimo's senior executives, including Chairman and CEO Joe Kiani, were aware that two noninvasive devices for measuring hemoglobin (Pronto & Pronto-7) in the blood gave unreliable readings.”

2. Judge Richard C. Neal concluded that “exhaustive evidence” provided by the claimants demonstrated that the two company devices at issue in the case (Pronto and Pronto-7), which non-invasively measure hemoglobin in the blood, were unreliable and inaccurate, did not meet the specifications the company claimed for the devices, and put patients at risk.

3. Masimo continued selling the devices “in the face of knowledge that the devices, at least in certain settings, could seriously endanger patients”

4. Justice Neal noted that “the highest ranking Masimo executives, including its Chairman and CEO, Joe Kiani, knew about the failures of their Pronto and Pronto-7; forced their sales staff to sell the devices ‘in the face of knowledge that the devices, at least in certain settings, could seriously endanger patients’; and were ‘unrepentant in the arbitration’ in the face of a wealth of evidence of wrong¬doing.”
http://www.ocregister.com/articles/masimo-601806-devices-neal.html
http://www.marketwatch.com/story/analyst-alert-multi-million-dollar-punitive-damage-award-won-by-bonagofsky-weiss-dickson-geesman-against-masimo-corporation-2014-02-13

Status: Case in Appeal
Case #14-55725: filed 5/2/14
Once arb suit vacated, the case advanced to U.S. Court of Appeals, Ninth Circuit
http://dockets.justia.com/docket/circuit-courts/ca9/14-55725
http://www.massdevice.com/news/judge-vacates-5m-arbitration-award-ex-reps-suit-against-masimo

 

Masimo is that wimpy kid in school that goes crying to teacher
when things don't go his way on the playground.

 

He doesn't share, take turns or fit in but that's okay. Command of the monkey bars is the sweetest victory.

 

"May limit adoption" is perhaps an understatement...

Kiani: "The State of California recently categorized SpCO as a laboratory test and therefore outside the scope of practice for EMS providers. Although a lack of inclusion into scope of practice procedures does not prohibit usage, it may limit adoption."
http://www.sec.gov/Archives/edgar/data/937556/000093755614000138/masi-20140927x10q.htm

 

Nelcor reps can recite these from memory
in their sleep

 

you guys seriously need to get a life!

 

Exposing unnecessary risks to patient care is my idea of doing "what's best for patient care," According to my business card, that's one of the guiding principles you hold me to, no? Careful what you preach jackass.

 

...says the Masimo manager

 

The good ones can

 

Did you ever get a high pronto reading on something dead? I am testing things around my apartment besides fingers and got a number. Any thing round to shove good into the clipy and stay there when I’m pushing all the buttons. There is not readings on hard things like a pole. That’s good. Some of my kitchen meats have hb! Can this be gross?
I Have this question, why? Upon putting potted chunk on our sandwich we meat tested my pronto before the bread and guess what, 15gdl. is blood in my canned meal! nobody warned me about it! the recipe of potted meat are these:: mechanically separated chicken, pork skin, partially defatted cooked pork fatty tissue, partially defatted cooked beef fatty tissue, beef tripe, artificial flavor, salt. mentioned no blood anywhere. “they say” blood waste is soaking in the sauce or it is injected into the animals joints between getting chopped down and mashed into tasty blocks of salty meat mix. My old lady said No more potted hb meat in this apartment please! Thanks a lot pronto!

 

Your frustration makes me whole again like a gust of brisk ocean air on my testes

 

There shouldn't be enough Hb in canned meat to register 15 g's.
I'd submit a complaint on that. Masimo can spring into action with a speedy investigation like never before (literally).

Holiday bonus....Walmart has 3 oz cans of potted meat on sale for $2/ea through New Years.
http://mobile.walmart.com/ip/Libby-s-Potted-Meat-Food-Product-3-Oz/10536024

 

Just another day in the weirdest house on the planet? WTF

 

apartment

 

$2 for 3 oz of nightmare ohh yes ohh yes I'm in at that price dawg

 

The most alarming communication I've seen from Masimo yet re: patient safety was their response to the FDA's observations last Oct..

Link to MASI's response to the FDA's observations detailed in Form 483's.
10/3/2013
https://www.documentcloud.org/documents/1307952-masimo-response-to-fda-inspection.html
FDA inspection report
https://www.documentcloud.org/documents/1305704-masimo-fda-inspection.html

 

If this defiant response of Masimo's to the FDA--rejecting or disagreeing with every listed 'observation'--is any indication of how the company's executive leadership team handles complaints....dare imagine how might they handle such complaints from subordinates, such as their own employees & paying customers.

 

Serves them right to be facing a federal criminal investigation and other stinky BS. The FDA has all the cause and authority they need to wreak havoc on these pissclams. Let's go uncle sam, how about sending a loud reminder to medical companies that patient safety won't be compromised, nor will defiance and hypocrisy be rewarded.

"Masimo hit with Federal Grand Jury Subpoena over patient-monitoring technology. Masimo CEO Joe Kiani and CFO Mark de Raad increased their guidance to $10 million (from $5 million) in anticipated legal fees by fiscal year-end 2014 due Masimo in cooperation with the DOJ's criminal investigation of the company."
http://www.fiercemedicaldevices.com/...ech/2014-05-09
http://www.sec.gov/Archives/edgar/da...0140508x8k.htm

 

The resulting FDA Warning letter and other challenges including the DOJ's criminal investigation now facing Masimo was inevitable if you ask me. The FDA has all the cause and authority they need to do their thing. Let's go uncle sam, how about sending a loud reminder to medical companies that patient safety won't be compromised, nor will defiance and hypocrisy be rewarded.

"Masimo hit with Federal Grand Jury Subpoena over patient-monitoring technology. Masimo CEO Joe Kiani and CFO Mark de Raad increased their guidance to $10 million (from $5 million) in anticipated legal fees by fiscal year-end 2014 due Masimo in cooperation with the DOJ's criminal investigation of the company."
http://www.fiercemedicaldevices.com/...ech/2014-05-09
http://www.sec.gov/Archives/edgar/da...0140508x8k.htm

 

I'm predicting an extreme outcome to this trial. It will either be so quiet no one ever knows what the hell happened, or it's going to be a nuclear blast.