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

Model Number	15
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A third party service agent performed an initial evaluation of the customer's device and verified the reported issue.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
A customer contacted physio control to report that their device would not complete its initial boot-up cycle.In this state, the device would not be able to provide defibrillation therapy, if needed.There was no patient use associated with the reported event.
Event or Problem Description
A customer contacted physio control to report that their device would not complete its initial boot-up cycle.In this state, the device would not be able to provide defibrillation therapy, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
The cause of the reported issue was isolated to the system pcb assembly.The device could however not be repaired, and was returned to the customer without repair.The customer was informed not to use the device.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 10754994
• Report Number: 0003015876-2020-01606
• Device Sequence Number: 13750976
• Product Code: MKJ
• UDI-Device Identifier: 00883873912041
• UDI-Public: 00883873912041
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2021

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: 99577-001229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1