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

Model Number	15
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the device and was able to verify and duplicate the reported issues.Investigation found the therapy pcba was the cause of the reported issues.The therapy pcba was replaced and calibrated to resolve the reported issues.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.
Event or Problem Description
The customer contacted stryker to report that a service indicator is present and event codes are logged in the memory of their device.The event codes indicate 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, as well as a potential failure of the device to deliver defibrillation energy.Upon evaluation of the customer's device, stryker observed that the device would not deliver defibrillation energy.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
The device's therapy pcba was returned to stryker's product analysis center (pac) for further investigation.It was determined the root cause was due to a shorted q8 on the h-bridge of the therapy pcba.
Event or Problem Description
The customer contacted stryker to report that a service indicator is present and event codes are logged in the memory of their device.The event codes indicate 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, as well as a potential failure of the device to deliver defibrillation energy.Upon evaluation of the customer's device, stryker observed that the device would not deliver defibrillation energy.There was no patient involvement reported with the event.

• 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 19959087
• Report Number: 0003015876-2024-02361
• Device Sequence Number: 7173939
• Product Code: MKJ
• UDI-Device Identifier: 00883873872093
• UDI-Public: 00883873872093
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 12/30/2024

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: 99577-001930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2016
• 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