MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION; DC-DEFIBRILLATOR, LOW-ENERGY (INCLUDING PADDLES)

Catalog Number	11131-000042
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer received replacement internal paddles.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 that their device's internal defibrillation paddles were not working.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted stryker to report that their device's internal defibrillation paddles were not working.As a result, defibrillation therapy may have been delayed or unavailable, if needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer's internal paddles and was unable to duplicate the reported issue.The internal paddles were archived by stryker.The cause of the reported issue could not be determined.

• Brand Name: HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION
• 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: 23134922
• Report Number: 0003015876-2025-01987
• Device Sequence Number: 8944355
• Product Code: LDD
• UDI-Device Identifier: 00883873863527
• UDI-Public: 00883873863527
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K895379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 3317813-007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 03/10/2026
• 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