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	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/26/2019
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 biphasic pcb assembly.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device failed the user test.Upon evaluation of the customer's device, physio observed that the device was delivering a monophasic energy output instead of a biphasic output and displayed an abnormal energy delivery message.As a result, the incorrect defibrillation therapy may be delivered.There was no patient use associated with this event.
Additional Manufacturer Narrative
Physio-control further evaluated the removed biphasic pcb assembly.It was determined that the cause of the reported issue was due to two transistors, designator q5 and q6.Both transistors were electrically shorted.
Event or Problem Description
The customer contacted physio-control to report that their device failed the user test.Upon evaluation of the customer's device, physio observed that the device was delivering a monophasic energy output instead of a biphasic output and displayed an abnormal energy delivery message.As a result, the incorrect defibrillation therapy may be delivered.There was no patient use associated with this event.

• 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: 9189178
• Report Number: 0003015876-2019-01685
• Device Sequence Number: 16778604
• Product Code: MKJ
• UDI-Device Identifier: 00883873912812
• UDI-Public: 00883873912812
• 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: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 15
• Device Catalogue Number: 99577-001215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1