US/Silver Spring: Physio-Control issues a Voluntary Field Action for all current Lifepak 1000 Defibrillators due to suspected operational failure, unexpectedly shut-down during patient treatment and possible death, a serious health hazard. FDA: http://ht.ly/UI8o3080aAk
Direct link: http://www.fda.gov/Safety/Recalls/ucm537114.htm
The US Food and Drug Administration (“FDA”) reports the following Medical Devices are subject to this Field Action:
- Lifepak 1000 Defibrillators
Please consult the photograph above for details of the device’s design and retail presentation.
==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.
According to the FDA, Physio-Control reports an intermittent connection between the battery and Defibrillator’s electrical contacts is a result of wear and subsequent oxidation formation between the battery and device electrical contacts.
This condition can occur over time in Lifepak 1000 Defibrillators exposed to vibration and have a battery installed for long periods of time. Owners with non-rechargeable batteries who do not routinely remove the battery for inspection, as specified in the Lifepak 1000 Defibrillators Operating Instructions, are more susceptible to this issue.
If this defect occurs, a Defibrillator may not be able to deliver necessary patient therapy during a resuscitation attempt. In turn, this may expose patients to the risk of serious harm or death. The company is aware of eight (8) adverse events related to this issue.
The FDA reports the company is contacting registered owners and advising them to immediately remove and reinstall the battery from their Defibrillator(s). Customers are also being advised to implement a weekly schedule of battery removal and reinstallation for all Lifepak 1000 devices. The removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring.
In addition, Physio-Control will be initiating a hardware device correction for all affected Lifepak 1000 devices and the company will contact customers to schedule device corrections once the hardware update is ready for implementation. The company will provide registered customers with updated information regarding the timing for this device correction at the website URL shown below, when it is available.
If you have any questions about this Field Action, please contact the company at 1-866-231-1220 from 6:00 AM to 4:00 PM Pacific Standard Time, on the Web at http://www.physio-control.com/lifepak1000-274 or e-mail at firstname.lastname@example.org.
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More information about this recall:
Recalls Direct RIN: 8127-2017
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Filed under: Assistive, health or safety devices, Death hazard, Food & Drink, Medical / Veterinary, US FDA | Tagged: death hazard, FDA, Lifepak 1000 Defibrillators, operational failure hazard, Physio-Control, Recalls Direct RIN: 8127-2017, US Food and Drug Administration |