MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. LIFEPAK; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 99507-000132

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 08/02/2022

Event Type  malfunction  

Event Description

Roughly 60% of lifepak 20e defibrillators hospital-wide are showing signs of stress-cracking in the form of hairline cracks along the top right side of the front panel case.The problem was originally discovered when two lifepak 20e's came in from the or with almost identical cracking patterns, the discovery of which prompted an investigation into the other likepack 20e's in the hospital, where 44 of 71 saw similar hairline cracks, or the beginnings of such cracking.All defibrillators were manufactured between october/2020 and december/2020.The widespread nature of such failure indicates a possible manufacturing flaw, a conclusion made after confirming the cleaning solutions used on these devices followed that of the cleaning requirements laid out in the lifepak 20e user's manual.Manufacturer response for defibrillator, lifepak (per site reporter).An account representative for the manufacturer was contacted in early august and we are still waiting for a response regarding this finding.

• Brand Name: LIFEPAK
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows rd ne; redmond WA 98052
• MDR Report Key: 15275016
• MDR Text Key: 298393752
• Report Number: 15275016
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/17/2022,08/16/2022

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 Catalogue Number: 99507-000132
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1