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

Model Number	15
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 10365696
• Report Number: 0003015876-2020-00997
• Device Sequence Number: 19408514
• Product Code: MKJ
• UDI-Device Identifier: 00883873911600
• UDI-Public: 00883873911600
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1