Class I Recall of Physio-Control's ReLIFEPAK15 Monitor Defibrillator
Physio-Control is recalling its LIFEPAK 15 Monitor/Defibrillator because the device may "lockup" (freeze) after a shock is delivered. When this occurs, the device's monitor display goes blank and there is no response from the keypad or the device although the device's LED lights remain on and indicates the device still has power.
Once the LIFEPAK 15 freezes, it cannot provide defibrillation therapy until the device is reset by restarting the device or removing and reinserting all connected power sources. The resulting delay in delivering a shock could and has resulted in serious patient injury including death.
The U.S. Food and Drug Administration (FDA) has classified this a Class I Recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product Information:
- Physio-Control, Inc. LIFEPAK15 Monitor/Defibrillator (LP15)
- Model: LIFEPAK 15 Monitor/Defibrillators with Printed Circuit Board Assembly (PCBA) part no. 3206834-011 or 3206834-012
- Serial/Lot Numbers: See "Full List of Affected Devices"
- Manufacturing Dates: March 21, 2013, to July 18, 2016
- Distribution Dates: March 21, 2013, to July 18, 2016
- Devices Recalled in the U.S.: 8,164
On February 1, 2019, Physio-Control sent customers an "Urgent Medical Device Safety Notice & Correction" letter. The letter informed customers that Physio-Control will provide a firmware update in the affected devices to resolve this issue. The letter also instructed customers to:
- Continue to use their LIFEPAK 15 Monitor/Defibrillator according to the device's Operating Instructions until the firmware correction can be completed.
- Continue to perform the daily check as described in the Operator's Checklist, specifically, the QUIK-COMBO Therapy Cable Check as described in the General Maintenance and Testing Section (pages 10-4, and the LIFEPAK 15 Monitor/Defibrillator Operator's Checklist, number 7).
- Immediately follow the steps from the General Troubleshooting Section (page 10-18) of the LIFEPAK 15 Monitor/Defibrillator Operating Instructions if a device exhibits a lockup condition during patient use:
- Press and hold the "ON" button for about 5 seconds until the LED turns off; then press the "ON" button to turn the device back on.
- If the device does not turn off, remove both batteries and disconnect the device from the power adapter, if applicable; reinsert batteries and reconnect the power adapter, then press the "ON" button to turn the device back on.
- Continue to perform cardiopulmonary resuscitation (CPR) while the above reset steps are followed.
Customers who have questions or need additional information regarding this recall should contact Stryker at 1-800-442-1142 (select option 7), from 6:00 AM - 4:00 PM, Monday through Friday (Pacific Time), or by emailing firstname.lastname@example.org or faxing to 1-425-867-4948.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Follow the link below for additional information.
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