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

Catalog Number	11131-000045
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The customer informed stryker that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.The customer will be provided with 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
A customer contacted stryker to report that the internal paddles of their device did not work.As a result, defibrillation therapy would not have been available, if needed.There were no reports of harm to the patient as a result of the reported event.
Additional Manufacturer Narrative
Stryker product analysis center (pac) evaluated the internal paddles and verified the reported issue.It was observed that the wire going into connector 13 is broken at the solder joint.
Event or Problem Description
A customer contacted stryker to report that the internal paddles of their device did not work.As a result, defibrillation therapy would not have been available, if needed.There were no reports of harm to the patient as a result of the reported event.

• Brand Name: DC-DEFIBRILLATOR, LOW-ENERGY (INCLUDING PADDLES)
• Common Device Name: INTERNAL 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: 23356177
• Report Number: 0003015876-2025-02189
• Device Sequence Number: 18442128
• Product Code: LDD
• UDI-Device Identifier: 00883873863497
• UDI-Public: 00883873863497
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/03/2026

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: 11131-000045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 02/03/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK 15 MONITOR/DEFIBRILLATOR, MKJ, SN UNKNOWN.
• Patient Sex: Unknown