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 Code	No Patient Involvement (2645)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control performed an initial evaluation of 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 is not completing the boot up process.As a result, defibrillation therapy may be unavailable, if it is needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control determined that the reported issue was the result of the system pcb assembly.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 is not completing the boot up process.As a result, defibrillation therapy may be unavailable, if it is 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 is not completing the boot up process.As a result, defibrillation therapy may be unavailable, if it is needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control further evaluated the removed system pcb assembly and determined the cause of the reported issue was due to a faulty single board computer.The customer received a replacement device and this device was scrapped.

• 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: 9211543
• Report Number: 0003015876-2019-01708
• Device Sequence Number: 13555441
• Product Code: MKJ
• UDI-Device Identifier: 00883873979105
• UDI-Public: 00883873979105
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2020

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: 99577-000085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 06/16/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 12/11/2019; 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1