MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20E

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

Stryker evaluated the device and was able to verify and duplicate the reported issue.Investigation determined the user interface pcba was the cause of the issue.The user interface pcba was replaced to resolve the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.

Event Description

The customer contacted stryker to report that their device was booting up with a completely white display.A white display can be indicative of a device lock up condition.As a result, defibrillation therapy may be unavailable, if it is needed.There was no patient use reported with the event.

• Brand Name: LIFEPAK® 20E DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 19210477
• MDR Text Key: 341367965
• Report Number: 0003015876-2024-01345
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2024

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: 20E
• Device Catalogue Number: 99507-000040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1