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

Catalog Number 11131-000001

Device Problem Key or Button Unresponsive/not Working (4063)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 325913537
• Report Number: 0003015876-2023-01924
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00883873824702
• UDI-Public: 00883873824702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 11131-000001
• Device Lot Number: 003593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 04/21/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LIFEPAK 15