MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 PADDLE ASSY - INTERNAL HANDLE; INTERNAL DEFIBRILLATION CABLES

Catalog Number	11131-000001
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was 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 that the shock button on their internal paddles handle was inoperable.The customer advised that during testing, the shock button did not work.In this state defibrillation therapy would be delayed or unavailable if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer's returned internal paddles and verified the reported issue.Stryker observed molding inside the cavity of the shock switch which impedes the movement of the button making it difficult to activate the shock button.The returned item was archived by stryker and the customer received a replacement.
Event or Problem Description
The customer contacted stryker to report that the shock button on their internal paddles handle was inoperable.The customer advised that during testing, the shock button did not work.In this state defibrillation therapy would be delayed or unavailable if needed.There was no patient use associated with the reported event.

• Brand Name: PADDLE ASSY - INTERNAL HANDLE
• Common Device Name: INTERNAL DEFIBRILLATION CABLES
• 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: 17954205
• Report Number: 0003015876-2023-01924
• Device Sequence Number: 7530763
• Product Code: LDD
• UDI-Device Identifier: 00883873824702
• UDI-Public: 00883873824702
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/23/2024

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: 11131-000001
• Device Lot Number: 003593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/21/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 04/23/2024
• 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
• Patient Sex: Unknown