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 Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customers device and duplicated the reported issue.Physio reconnected the device's cable, designated w13, which had become disconnected at the user interface pcb.Unrelated repairs were completed.Proper device operation was observed 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 had no power.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient use associated with the reported 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: 9690451
• Report Number: 0003015876-2020-00187
• Device Sequence Number: 11368242
• Product Code: MKJ
• UDI-Device Identifier: 00883873979020
• UDI-Public: 00883873979020
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/10/2020

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: 99577-000093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1