MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 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 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer¿s device and verified the reported issue.Physio-control replaced the user interface pcb assembly.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.Physio further evaluated the removed user interface pcb assembly.Physio determined that the cause of the reported issue was due to integrated circuit (ic), designator u2.The memory of u2 was corrupt.

Event Description

The customer contacted physio-control to report a non-critical issue with their device.Upon evaluation of the customer¿s device, physio-control observed that the device was unable to complete a boot cycle and displayed a white screen.Physio also observed an event logged in the device memory that is related to a device lockup.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 12706029
• MDR Text Key: 278629232
• Report Number: 0003015876-2021-02065
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873887707
• UDI-Public: 00883873887707
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2021

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: 99507-000102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2014
• 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