COVIDIEN-NEW VENTILATOR

Discussion in 'Covidien' started by Anonymous, Feb 14, 2013 at 11:08 PM.

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  1. Anonymous

    Anonymous Guest

    2 projects in the acquisition pipeline, Newport fills out mid range. 2015 will be a bloodletting when sale occurs. Company not likely to be spun off. Standalone organisation wont have resources to compete with the likes of Draeger, Maquet, Carefusion, GE, etc.

    Course leadership is telling everyone it will be fine. Disruption in revenue, deviation from forecast, missed dev project milestone or FDA compliance issue will cause valuation problems. Get CV up to date. Ventilation not a growth business.

    Naïve to trust leadership. They cut people loose if it looks like they won't get their bonus. How many execs at Covidien taken a $1 salary in lieu of RIF'ing people? How many execs VP and over RIF'd over the years? If BU is underperforming, the issue is with their leadership and abilities, they should take one for the team.

    980 510k submitted 1/5/13. Concurrence 24/2/14. 9 month review for a 90 day 510k sign of a company w little or no credibility w the FDA and issues w the submission itself. It begs the question. 510k states zero approved claims re clinical performance of the vent. Still not in Mayo.
     

  2. Anonymous

    Anonymous Guest

    Unreal! Makes sense why they are giving 2 for 1 deals. Pizza pizza
     
  3. Anonymous

    Anonymous Guest

    WOW - what else?
     
  4. Anonymous

    Anonymous Guest

    What's the deal here? Are these just pissed off reps, or can someone from a hospital go on record! Has anyone had any issues or just the usual jitters. From what I see this vent is pretty solid..even if it does not have any new bells..
     
  5. Anonymous

    Anonymous Guest

    It Has several software glitches and a couple hardware issues as well. There's already recalls in a couple other countries. Do your research. At this point it can't do basic ventilation safely yet alone new bells.
     
  6. Anonymous

    Anonymous Guest

    thanks for the heads up, looks like the 980 is picking up right where the 840 left off. it really is too bad, it looks like a great product. Guessing they spent the money on great paint and not so much on the under the hood.
     
  7. Anonymous

    Anonymous Guest

  8. Anonymous

    Anonymous Guest

    The Australia one looks to be bogus. How can a device that was only approved six months ago have recalls already?

    I am sure the US did a better job looking at its premarket submission.
     
  9. Anonymous

    Anonymous Guest

    Pmas are required for class iii devices w 180 day review and r contingent on meeting endpoints in fda approved clinical trial. 980 is 510K or class ii device with 90 day fda review and NO clinical trial. Instead of 90 days 980 review took ovr 8 mos due 2 history 840 probs and probs w submission.

    Ventilation 510k based on v little clinical data. All cov has to do is prove equivalence to predicate device already approved ie 840, 840 510k ties back to previous vent, and previous vent, and previous vent. 510k really house of cards with very little rigor beyond bench testing.

    If you think they didn't know abt most 980 issues ur crazy. 980 shoved out b4 paint dried cos company couldn't book new revenue in markets like EU (2nd biggest) due to ROHS. U should see feature list cut from 980. 840 wuz being smacked arnd by teh comp in field, cmon 14+ y/o platform. JWs call btw. Reps last few years r rock stars putting up w his poor judgment and integrity issues.

    Omar likely 2 cut rms, no strategic fit. Line up ur plan Bs. Won't happn right away but will regardless the line of bull were being fed. Mallinckrodt>tyco>cov>? Who's next? ResMed maybe and move back to Cali for the very few Boulder ppl that make the cut? R&d facility and acquirer would already be there. Many functions redundant so they'll b deep.
     
  10. Anonymous

    Anonymous Guest

    Some issues reported now on maude. Under 980 ventilator search. Some just look like typical start up bugginess.

    Reps here are saying to wait for v 2.0
     
  11. Anonymous

    Anonymous Guest

    Company buries complaints and doesn't report many. Maude isn't reliable because it's tied to each company.

    Not exactly a ringing endorsement when sales reps for the device, many of whom are former RTs, are saying wait. Btw v2 is a long way off.
     
  12. Anonymous

    Anonymous Guest

  13. Anonymous

    Anonymous Guest

    this latest software glitch sounds bad, 980 looks to have the same glitches the 840 had in Janaury.
    I dont think i would want this on my patients, probaly give them 12 months to work out the kinks..
     
  14. Anonymous

    Anonymous Guest

    Barely a mention of the 980 on earnings call. We're joes statements misleading? Forgot to mention forecasts were revised what, 3 times this year, and nary a mention of the recalls. Covidien leadership integrity at its best.
     
  15. Anonymous

    Anonymous Guest


    Too lazy to spell correctly?
     
  16. Anonymous

    Anonymous Guest

    Let me get this straight, there have been posts in this thread highlighting RMS sales involvement in the physician grant process, leadership engaging in quid pro quo, reps selling at physician training, intentionally "losing" complaints that put patients' lives at risk, acting slowly to fix complaints it doesn't "lose" like the 840 one that started in Australia, major Class 1 recall on the 840 in January that spanned years of devices in multiple countries, refused to pull engineers from the 980 to fix issues with the 840 that it knew about like the aforementioned class 1 shutdown recall, a former 980 engineer stated on this thread that the development process was flawed and would result in a few class 1 980 recalls, lo and behold there is a 980 class 1 recall on the not long ago FDA approved 980 in multiple countries no less, at leaderships direction company presold the 980, also at the direction of leadership Covidien sold both the 840 and 980 knowingly with defects which is Medicare fraud, leadership violated AKS, 980 is banned from one of the most notable healthcare groups aka Mayo, company made offlabel claims about the effectiveness of PAV with 840 for years, haven't even gotten into the whole 980 natural breathing and sedation or med reduction messages really are performance claims that require data or Willett's highly unethical morally bankrupt initiative to "secretly" ship 980 ventilators through Europe so they couldn't be traced to the US to test them on 2 patients in a Central American country before they were ever tested on animals. Pretty sure that last bit meets the definition of moral turpitude.

    To top it off, reps and clin specs are recommending customers wait for 980 version 2.0 and people reported many of these issues to the ombudsman, nothing was done and the people that tried to do the right thing were either forced or pushed out in retaliation likely by leadership who probably consulted both compliance and employment counsel, sounds like one person has gone to DOJ and another one or two is in the wings.

    All you care about is someone's fucking spelling? Enjoy the RIF or reorg in the works.
     
  17. Anonymous

    Anonymous Guest

    Sounds a lot like the shit that has gone on in the Vascular Therapies division.. DOJ is sniffing around over there...
     
  18. Anonymous

    Anonymous Guest

    Any good news from AARC in Vegas? 2.0? Competition? Medtronic? FDA? JW?
     
  19. Anonymous

    Anonymous Guest

    LOL!!!The new ServoU will be 980 killing machine. So neat and flexible. State of the art GUI. Amazing neo capabilities. Nava, hotwire proximal sensor and leakage compensation etc etc