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	08/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer received replacement internal paddles.The internal paddles were not returned to stryker for evaluation.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report a set of internal defibrillation paddles is not working.As a result, defibrillation therapy may be unavailable, if needed.There was no report of patient use associated with the reported event.

• 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: 20216311
• Report Number: 0003015876-2024-02634
• Device Sequence Number: 18107309
• Product Code: LDD
• UDI-Device Identifier: 00883873863527
• UDI-Public: 00883873863527
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/13/2024

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: 11131-000042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2024
• Initial Report FDA Received Date: 09/13/2024
• 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