MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 99400-003765

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

The third-party service agent evaluated the customer's device and replaced the therapy pcb assembly and performed other unrelated repairs.Proper device operation was then observed through functional and performance testing.The device was subsequently returned to the customer.The replaced therapy pcb assembly was requested to be sent to the pac (product analysis center) for the further investigation.

Event Description

A third party service agent contacted physio control to report that upon the initial evaluation of the customer's device they observed that the device would continuously deliver defibrillation energy.There was no patient use associated with the reported event.

Manufacturer Narrative

It was determined that the root cause of the reported issue is a partially shorted resistor, r1, on the therapy pcb assembly.

Event Description

A third party service agent contacted physio control to report that upon the initial evaluation of the customer's device they observed that the device would continuously deliver defibrillation energy.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
• 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: 11722261
• MDR Text Key: 247599206
• Report Number: 0003015876-2021-00907
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K102972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 99400-003765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1