MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	99400-003505
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated 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 the service indicator was present on their device.There was no patient use associated with the reported issue.Upon evaluation of the customer's device, physio-control observed that the device is unable to defibrillate above 15 joules.The device would charge; however when pressing the shock button, the device would not deliver defibrillation energy.
Event or Problem Description
The customer contacted physio-control to report that the service indicator was present on their device.There was no patient use associated with the reported issue.Upon evaluation of the customer's device, physio-control observed that the device is unable to defibrillate above 15 joules.The device would charge; however when pressing the shock button, the device would not deliver defibrillation energy.
Additional Manufacturer Narrative
Physio-control determined that the cause of the reported issue was due to the therapy pcb assembly.After replacing the therapy pcb assembly and reseating the therapy pcb assembly connection, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the removed therapy pcb assembly and was unable to duplicate the reported issue and no further root cause could be determined.

• Brand Name: LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES
• 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: 8291417
• Report Number: 0003015876-2019-00170
• Device Sequence Number: 1947275
• Product Code: MKJ
• UDI-Device Identifier: 00885074857749
• UDI-Public: 00885074857749
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K102972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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 Catalogue Number: 99400-003505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1