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 Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2019
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 was not powering up all the way during a patient event.As a result, defibrillation therapy may have been unavailable, if it was needed.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Additional Manufacturer Narrative
Physio-control determined that the cause of the reported issue was due to 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 was not powering up all the way during a patient event.As a result, defibrillation therapy may have been unavailable, if it was needed.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Event or Problem Description
The customer contacted physio-control to report that their device was not powering up all the way during a patient event.As a result, defibrillation therapy may have been unavailable, if it was needed.There were no reports of any adverse effects to the patient as a result of the reported issue.Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.
Additional Manufacturer Narrative
Physio-control further evaluated the removed system pcb assembly and determined that the cause of the reported issue was due to a faulty single board computer.Physio disposed of the customer's device and the customer received a replacement device.

• 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: 8813638
• Report Number: 0003015876-2019-01241
• Device Sequence Number: 2743026
• Product Code: MKJ
• UDI-Device Identifier: 00883873988114
• UDI-Public: 00883873988114
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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: 99577-000037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 03/25/2020
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/23/2019; 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1