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

Model Number 15

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control evaluated the customer¿s device and verified the reported issue.Physio replaced the therapy pcb assembly and the transfer relay assembly, and then observed proper device operation through functional and performance testing.The device was returned to the customer for use.

Event Description

The customer contacted physio-control to report that their device displayed ¿abnormal energy delivery¿ when delivering defibrillation therapy during testing.In this state, the device may not have the ability to deliver appropriate defibrillation therapy.There was no patient use associated with the reported event.

Manufacturer Narrative

Physio-control determined that the cause of the reported issue was due to the system pcb assembly, the part had failed.No further root cause could be determined.

Event Description

The customer contacted physio-control to report that their device displayed ¿abnormal energy delivery¿ when delivering defibrillation therapy during testing.In this state, the device may not have the ability to deliver appropriate defibrillation therapy.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: 10365696
• MDR Text Key: 201665278
• Report Number: 0003015876-2020-00997
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873911600
• UDI-Public: 00883873911600
• Combination Product (y/n): N
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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: 99577-001258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1