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

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control performed an evaluation of the customer device and was unable to duplicate the reported event.Based on discussion with customer, the power pcb and battery pins were replaced as a precaution.Physio performed unrelated repairs and the device passed functional and performance testing and was returned to the customer.
Event or Problem Description
The customer contacted physio-control to report that their device shut down unexpectedly.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device shut down unexpectedly.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the device download data and verified the issue.Further cause could not be determined.

• 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: 10610645
• Report Number: 0003015876-2020-01367
• Device Sequence Number: 3806262
• Product Code: MKJ
• UDI-Device Identifier: 00883873884348
• UDI-Public: 00883873884348
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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: UNK_SMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1