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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer¿s device and verified the non-critical reported issue.Physio also observed only the power button to be operational.Physio replaced the interface pcb assembly to resolve both issues.After observing 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 a non-critical issue with their device.Upon evaluation of the customer¿s device, physio-control observed that the customer's device was able turn on with the power button; however no other buttons were functioning.In this state defibrillation therapy may not be available to a patient if needed.There was no patient use associated with this event.
Additional Manufacturer Narrative
Physio-control further evaluated the removed user interface pcb assembly.Physio determined that the cause of the reported issue was due to integrated circuit, designator u5.U5 was electrically damaged.
Event or Problem 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 customer's device was able turn on with the power button; however no other buttons were functioning.In this state defibrillation therapy may not be available to a patient if needed.There was no patient use associated with this 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: 10263115
• Report Number: 0003015876-2020-00869
• Device Sequence Number: 3043843
• Product Code: MKJ
• UDI-Device Identifier: 00883873911778
• UDI-Public: 00883873911778
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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: 99577-001242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1