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 Charge (1085)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio control evaluated the customers device and was unable to duplicate the reported issue.Physio control reviewed the device data and discovered a transient event code in the devices memory that is indicative of a failure of the device to charge for defibrillation.Physio cleared event codes from the device memory and upon testing did not observed a return of the event codes.After completing other unrelated repairs, 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 a non-critical issue with their device.Upon evaluation physio found a device code logged in the device's memory that is indicative of a failure of the device to charge for defibrillation.There was no 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: 8956645
• Report Number: 0003015876-2019-01467
• Device Sequence Number: 13991143
• Product Code: MKJ
• UDI-Device Identifier: 00883873871836
• UDI-Public: 00883873871836
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2019

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: 99577-001943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1