Il semblerait que certaines irrégularités dans la qualité du processus
de fabrication soient responsables de cet arrêt d'expédition des
défibrillateurs LIFEPAK, tous modèles confondus.
Pour ceux qui sont en processus de renouvellement de moniteurs
défibrillateurs, ainsi que de défibrillateurs externes automatisés, je
suggère de contacter votre représentant Medtronic/LifePak.
Salutations
Stéphan Gascon
-------------------------------
http://fe.pennnet.com/display_article/282456/25/ARTCL/none/HOME/Medtronic-unit-halts-defibrillator-sales
Medtronic unit halts defibrillator sales
Medtronic's Physio-Control unit indefinitely suspended shipments of
external defibrillators and other emergency-response gear because of
quality-control problems at a factory in Redmond, Washington. The
suspension will address weaknesses in "the overall quality system" in
the Redmond factory that were identified by the U.S. Food and Drug
Administration and the company, Medtronic spokesman Rob Clark said. The
quality issues are related to manufacturing processes and not any
individual products, he said. No products are being recalled. The
halting of product shipments means that Medtronic will delay the spinoff
of Physio-Control as an independent public company, which had been
planned for mid-2007.
Medtronic did not fix defibrillator flaws
In a letter made public June 21, 2005, the U.S. Food and Drug
Administration warned Medtronic Emergency Response System
http://www.fda.gov/foi/warning_letters/g5357d.htm,
a unit of Medtronic, Inc., that its failure to correct manufacturing
problems or investigate complaints regarding its LifePak 12 external
defibrillators may force the company to face civil and legal penalties.
External defibrillators deliver powerful electrical shocks to the chest
in order to restore the heart's natural rhythm.
The letter highlighted a problem with the LifePak 12 involving broken or
bent pins in therapy cables connected to the device, which is used to
treat patients experiencing sudden cardiac arrest. The damaged cables in
some of the LifePak 12 defibrillators caused them to deliver
inappropriate energy levels while in use, resulting in numerous complaints.
The FDA inspected Medtronic's plant in Redmond, WA, in February and
March, 2005, on several occasions after Medtronic recalled about 87,000
units of another implantable defibrillator after the discovery of
battery failures. At that time Medtronic promised to remedy
manufacturing problems despite citing an "internal analysis" of the
LifePak 12, which they claimed revealed no issues with the device. The
recently published letter by the FDA states that Medtronic has failed to
adequately correct manufacturing problems related to its defibrillators.
The company also violated its own internal safety procedures when it did
not open an investigation on a defibrillator complaint involving a
patient death. The letter stated, "There have been continued complaints
of broken pins in the therapy cables used with the new redacted
connector" intended to remedy the flaw. The FDA pointed to inadequate
inspection procedures as one possible source of the problem.
Earlier this year, Medtronic recalled 1,924 LifePak 500 external
defibrillators due to 54 incident reports about a malfunction in the
model that caused the units to display a "connect electrodes" message
even when the device was properly connected. This flaw prevented
patients from being properly defibrillated. The Redmond facility in
which they were manufactured was previously owned by Physio-Control, a
Washington company that first commercialized the defibrillator.
Manufacturing in the facility was shut down for an entire year in 1992
after an FDA inspection raised questions about its quality-control
procedures.
FDA Shutdown in 1992
In 1992, Physio-Control voluntarily shut down production of its
defibrillators and patient monitors after a review by the U.S. Food and
Drug Administration found the company had failed to follow "good
manufacturing practices," including inadequate failure investigations,
not properly inspecting critical components of its products, and failing
to adequately document manufacturing and testing procedures in writing.
Although the FDA never claimed that patients had been harmed by
malfunctions of the medical equipment, and no recalls were ordered,
Physio-Control signed a consent decree outlining steps it would take
before resuming production. Richard O. Martin, former vice president of
business development who had succeeded Anderson as president and chief
executive in 1991, later told the Puget Sound Business Journal that
Physio-Control "truly, fundamentally believed" that it was in compliance
with all FDA requirements. He blamed the sanctions on political pressure
then being brought to bear on the FDA to become more forceful in its
interpretation of the rules.
Reaction
Fire Engineering EMS Editor Mike McEvoy said the Medtronic announcement
is reminiscent of the 18 month shutdown in 1992 after the FDA found the
company had failed to follow "good manufacturing practices." With over
600,000 defibrillators and AEDs deployed in the United States, Medtronic
Emergency Response Systems controls some 70% of the US EMS market and
nearly 50% of the in-hospital market for external defibrillators.
External links
* Read the Medtronic press release
http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1169044952387&lang=en_US
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