MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	20
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and verified the reported issue.Physio replaced the therapy pcb assembly.Thereafter proper device operation was observed through functional and performance testing and the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that during testing of their device they heard a "pop" sound and smelled smoke.Upon evaluation of the customer¿s device, physio-control observed that the device was unable to deliver defibrillation energy and displayed an ¿abnormal energy delivery¿ message.The device shocked but there was no energy output.There was no patient use associated with this event.
Additional Manufacturer Narrative
Physio-control further evaluated the removed therapy pcb assembly.It was determined that the cause of the reported issue was due to diode, designator cr30.Legs 5 and 9 of cr30 were electrically shorted which resulted in catastrophic damage.
Event or Problem Description
The customer contacted physio-control to report that during testing of their device they heard a "pop" sound and smelled smoke.Upon evaluation of the customer¿s device, physio-control observed that the device was unable to deliver defibrillation energy and displayed an ¿abnormal energy delivery¿ message.The device shocked but there was no energy output.There was no patient use associated with this event.

• Brand Name: LIFEPAK(R) 20 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: 8791780
• Report Number: 0003015876-2019-01219
• Device Sequence Number: 14119945
• Product Code: MKJ
• UDI-Device Identifier: 00883873813782
• UDI-Public: 00883873813782
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• 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): 08/28/2019

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 Model Number: 20
• Device Catalogue Number: 99402-000067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1