MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned to physio-control for evaluation.A third-party service agent evaluated the device and verified the reported issue.After replacing the system pcb assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device froze during the self test after booting, while checking the device during a daily test.The device illuminated its service led and was only able to power off by removing the batteries.This behaviour is indicative of a lock-up.In this state the device would not be able to charge or shock defibrillation energy, when needed.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control further evaluated the system pcb assembly, and determined that the cause of the reported issue was due to a failure of the single board computer (sbc).

Event Description

The customer contacted physio-control to report that their device froze during the self test after booting, while checking the device during a daily test.The device illuminated its service led and was only able to power off by removing the batteries.This behaviour is indicative of a lock-up.In this state the device would not be able to charge or shock defibrillation energy, when needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 7612664
• MDR Text Key: 111861962
• Report Number: 0003015876-2018-00958
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-000165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1