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

Model Number	15
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was not able to provide any further information.Patient fields in which information was not provided were intentionally left blank.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted physio-control to report that their device went completely blank on a ems call while changing one of the two batteries on the device.No further information was able to be provided.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient harm associated with the reported event.
Additional Manufacturer Narrative
The customer contacted physio-control to clarify that there was no patient involvement.Section a1 patient identifier of the initial medwatch report was blank.Section a1 patient identifier of the initial medwatch report should indicate: none.
Event or Problem Description
The customer contacted physio-control to report that their device went completely blank on a ems call while changing one of the two batteries on the device.No further information was able to be provided.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient harm associated with the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and the reported issue was duplicated.The device's electronic records were reviewed and no patient events were logged for the reported event date; the reported issue could not be verified.Physio replaced the device's power pcb, battery wire harness, and battery pins to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The removed power pcb was scrapped.The root cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device went completely blank on a ems call while changing one of the two batteries on the device.No further information was able to be provided.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient harm 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: 10359426
• Report Number: 0003015876-2020-00985
• Device Sequence Number: 11345343
• Product Code: MKJ
• UDI-Device Identifier: 00883873911709
• UDI-Public: 00883873911709
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup,Followup
• Report Date (Section B): 12/15/2020

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: 99577-001249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 08/10/2020; 12/10/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/12/2020; 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1