MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 PADDLE ASSY-HARD PADDLE,ENGLISH, ROHS, LP15; AUTOMATED EXTERNAL DEFIBRILLATOR PADDLES

Catalog Number	11130-000061
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted stryker to report the device would not work when hooked up to the defib machine.As a result, defibrillation therapy may be unavailable if it was needed.There was no patient involvement reported with the event.
Event or Problem Description
The customer contacted stryker to report the device would not work when hooked up to the defib machine.As a result, defibrillation therapy may be unavailable if it was needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and duplicated the reported issue.The device is not recognized when initially plugged and and could not be reproduced thereafter.This device was archived by stryker.A conclusive root cause of the reported issue could not be determined.

• Brand Name: PADDLE ASSY-HARD PADDLE,ENGLISH, ROHS, LP15
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR PADDLES
• 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: 22456559
• Report Number: 0003015876-2025-01390
• Device Sequence Number: 12857907
• Product Code: MKJ
• UDI-Device Identifier: 00883873989814
• UDI-Public: 00883873989814
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/26/2025

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 Catalogue Number: 11130-000061
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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