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

Model Number	15
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device had an event code logged in its memory and also delivered a lower energy shock than the level selected.The event code logged in the device's memory may be associated with a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.This would result in a monophasic shock being delivered.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and verified the reported issue.Stryker replaced the device's therapy pcb assembly to resolve the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
Additional Manufacturer Narrative
Stryker further evaluated the removed therapy pcb assembly and determined that the cause of the reported issue was due to a partially shorted transistor, designator q7.
Event or Problem Description
The customer contacted stryker to report that their device had an event code logged in its memory and also delivered a lower energy shock than the level selected.The event code logged in the device's memory may be associated with a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.This would result in a monophasic shock being delivered.There was no patient use associated with the reported 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: 19335003
• Report Number: 0003015876-2024-01622
• Device Sequence Number: 3009705
• Product Code: MKJ
• UDI-Device Identifier: 00883873871874
• UDI-Public: 00883873871874
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• 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): 09/27/2024

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: 99577-001939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2019
• 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