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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the customer¿s device and verified the reported issue.Stryker replaced the therapy pcb assembly and then observed proper device operation through functional and performance testing and the device was returned to the customer for use.Stryker further evaluated the removed therapy pcb assembly.It was observed that transistor, designator q8 was partially electrically shorted.This caused the service code and abnormal energy delivery message with 80% of target energy being delivered in a monophasic waveform.
Event or Problem Description
The customer contacted stryker to report that their device failed the user test and logged an event code in the device¿s memory that is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock.Additionally, the defibrillator output energy may be reduced by up to approximately 20% from the selected energy level.As a result, the wrong defibrillation therapy would be delivered, if it were necessary.There was no patient use associated with the reported 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17764026
• Report Number: 0003015876-2023-01678
• Device Sequence Number: 7093866
• Product Code: MKJ
• UDI-Device Identifier: 00883873871768
• UDI-Public: 00883873871768
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2023

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: 99577-001950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown