MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	11131-000045
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device paddles did not deliver energy when the shock button was pushed.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
Stryker product assessment center evaluated the customer's returned paddles and was unable to duplicate the reported issue.The cause of the reported issue could not be determined.The customer received replacement paddles.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.

• Brand Name: HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION
• 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: 20126502
• Report Number: 0003015876-2024-02540
• Device Sequence Number: 7417278
• Product Code: MKJ
• UDI-Device Identifier: 00883873863497
• UDI-Public: 00883873863497
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 09/03/2024

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown