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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified that the event code was logged in the device's memory; however, the issue could not be duplicated during testing.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the device had an event code logged in its memory.The event code logged in the device's memory is indicative of a failure of the device to charge defibrillation energy.As a result, defibrillation therapy may not be available, if needed.

• 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: 12351113
• Report Number: 0003015876-2021-01652
• Device Sequence Number: 17220710
• Product Code: MKJ
• UDI-Device Identifier: 00883873912775
• UDI-Public: 00883873912775
• 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: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: 99577-001219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1