MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 ASSEMBLY, INTERNAL PADDLES, LP20, 2.3; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Catalog Number	11131-000042
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
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.Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.
Event or Problem Description
The customer contacted stryker to report that their device's sterilizable internal paddles were cracked and failed during patient use.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however, there was no adverse event reported.
Event or Problem Description
The customer contacted stryker to report that their device's sterilizable internal paddles were cracked and failed during patient use.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however, there was no adverse event reported.
Additional Manufacturer Narrative
The paddles were not returned to stryker redmond for further evaluation and images of the paddles were not provided by the customer.As such, the reported issue could not be verified or duplicated, and a conclusive root cause could not be determined.

• Brand Name: ASSEMBLY, INTERNAL PADDLES, LP20, 2.3
• Common Device Name: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING 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: 21688214
• Report Number: 0003015876-2025-00591
• Device Sequence Number: 21015385
• Product Code: LDD
• UDI-Device Identifier: 00883873863527
• UDI-Public: 00883873863527
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K895379
• 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): 06/06/2025

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: 11131-000042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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