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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.No additional information was available and no known impact or consequence to patient was reported.Physio-control evaluated the customers device and was unable to duplicate the reported issue.Unrelated repairs were completed and 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 when their device was turned on, the green power button turned on but the screen was blank.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of any adverse effect to the patient as a result of the reported issue.

• 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: 9556561
• Report Number: 0003015876-2020-00037
• Device Sequence Number: 11331635
• Product Code: MKJ
• UDI-Device Identifier: 00883873814185
• UDI-Public: 00883873814185
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-000006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1