MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 ASSEMBLY, INTERNAL PADDLES; INTERNAL DEFIBRILLATION CABLES

Catalog Number 11131-000041

Device Problem Device Sensing Problem (2917)

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

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

Stryker observed that one of the pins of the internal paddles measured an open.As a result the internal paddles would not be sensed by a device.An x-ray image taken confirmed a wire had broken off of pin 6 internally.The cause of the observed issue was due to a broken internal wire, further cause could not be determined.The customer received a replacement internal paddle set and the returned paddles were archived by stryker.

Event Description

The customer contacted stryker to report a non-critical issue with their internal paddles.Upon evaluation of the customer¿s device, stryker observed that one of the pins of the internal paddles measured an open.As a result the internal paddles would not be sensed by a device.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.

• Brand Name: ASSEMBLY, INTERNAL PADDLES
• 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: 18814565
• MDR Text Key: 336644385
• Report Number: 0003015876-2024-00476
• Device Sequence Number: 1
• Product Code: LDD
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11131-000041
• Device Lot Number: 003056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Date Manufacturer Received: 02/29/2024
• 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