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

Model Number	15
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customers device and verified the reported issue.Physio replaced the device's therapy pcb assembly to resolve the reported issue.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the removed therapy pcb assembly and determined a leaking capacitor designator c160 was the cause of the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device fails the user test.Upon evaluation physio confirmed the issue noting the service indicator was illuminate and an event code was logged in the devices memory.The event code logged in the device's memory can indicate that the aed function of the device may be inoperable.As a result, the unit may not be able to analyze a patient's rhythm and provide defibrillation therapy while in aed mode, if it was necessary.There was no patient use reported with the event.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• 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: 9781073
• Report Number: 0003015876-2020-00316
• Device Sequence Number: 11386908
• Product Code: MKJ
• UDI-Device Identifier: 00883873911723
• UDI-Public: 00883873911723
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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: 99577-001247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1