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

Model Number	15
Medical Device Problem Codes	Failure to Power Up (1476); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control performed an initial evaluation on the customer's device and verified the reported issue.Physio-control continues to investigate the reported failure 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 freezes at the self-test start up menu.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control further evaluated the customers device and the system control pcb assembly was determined to be the cause of the reported issue.At this time, this device cannot be repaired due to part obsolescence.The customer has received a loaner until a permanent solution for this complaint is identified.
Event or Problem Description
The customer contacted physio-control to report that their device freezes at the self-test start up menu.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control further evaluated the removed system pcb assembly and determined a faulty single board computer card was the cause of the reported issue.
Event or Problem Description
The customer contacted physio-control to report that their device freezes at the self-test start up menu.In this state the device would be inoperable and defibrillation therapy would not be available if needed.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: 8935580
• Report Number: 0003015876-2019-01431
• Device Sequence Number: 1746802
• Product Code: MKJ
• UDI-Device Identifier: 00883873979419
• UDI-Public: 00883873979419
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2020

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: 99577-000056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 10/02/2019; 03/25/2020
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/03/2019; 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1