LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in t

FDA device recall Z-0294-2018 · posted 2018-01-11 · Terminated

Recall details

Recalling firm

Physio-Control, Inc.

Reason for recall

Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.

Action taken

The recall was initiated by letter on 12/04/2017. The recall notice stated: "Physio-Control s Planned Actions Physio-Control will contact customers with LIFEPAK 20e devices who are potentially affected to arrange for a device correction. This correction will include the replacement of the Power PCBA. Required Customer Actions 1. Please forward this letter to all of your sites, trainers, and users that have an affected LIFEPAK 20e device(s) as identified on the attached Confirmation Sheet. 2. Promptly return the completed Confirmation Sheet to Physio-Control. 3. Follow the recommended daily Operator s Checklist steps in accordance with LIFEPAK 20e defibrillator/monitor Operating Instructions Section 7 Maintaining the Equipment. The checklist can be found in Appendix D of the Operating Instructions. 4. You may continue to use your defibrillator/monitor as long as it passes steps 1 and 8 of the Operator s Checklist. 5. If you experience any of the symptoms described above, or the defibrillator/monitor fails steps 1 and/or 8 of the Operator s Checklist, contact Physio-Control immediately to arrange servicing of your device. If your LIFEPAK 20e defibrillator/monitor exhibits any power issues that cannot be resolved, contact Physio-Control immediately. Contact Physio-Control if you have any questions about this matter at 1-800-442-1142, option 7, 6:00 A.M. to 4:00 P.M. (PST), Monday Friday."

Root cause

Other

Status

Terminated

Product code

MKJ

Quantity affected

3831 units

Distribution

Worldwide Distribution

Date initiated

2017-12-04

Date posted

2018-01-11

Date terminated

2024-04-01

Location

Redmond, WA

Related 510(k) clearances