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

Model Number	15
Medical Device Problem Code	Aborted Charge (2288)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A loaner was provided to the customer.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
The customer contacted physio-control to report that their device aborted the charge prior to therapy being delivered.In this state, the device may not be able to deliver defibrillation energy to a patient if needed.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device aborted the charge prior to therapy being delivered.In this state, the device may not be able to deliver defibrillation energy to a patient if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control evaluated the device and was unable to duplicate or verify the reported issue.Physio tested the device and it charged appropriately and delivered energy in specification.After performing unrelated repairs, physio observed normal device operation through functional and performance testing and returned the device to the customer.Physio reviewed the device download data; the reported issue could not be verified and the root 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: 9316442
• Report Number: 0003015876-2019-01830
• Device Sequence Number: 13570045
• Product Code: MKJ
• UDI-Device Identifier: 00883873871812
• UDI-Public: 00883873871812
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 01/02/2020

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: 99577-001945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1