MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 15AACBABBABBBAAAAAAAAAABLP15 MONITOR/DEFIB; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Codes	Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker evaluated the device and verified the observed issue.Stryker determined that the cause of the reported issue was due to an unseated capacitor to therapy pcb cable.Stryker reseated the cable to resolve the issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to stryker loaner inventory.
Event or Problem Description
Stryker was performing preventative maintenance on a stryker-owned loaner device and observed that the device does not deliver defibrillation energy when shocking.It also displays an "abnormal energy delivery" message.As a result, defibrillation therapy may be unavailable, if needed.There was no patient use associated with the reported event.

• Brand Name: 15AACBABBABBBAAAAAAAAAABLP15 MONITOR/DEFIB
• 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: 22847390
• Report Number: 0003015876-2025-01689
• Device Sequence Number: 8373569
• Product Code: MKJ
• UDI-Device Identifier: 00883873911631
• UDI-Public: 00883873911631
• 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
• Report Date (Section B): 08/20/2025

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: 99577-001256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2013
• 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