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  

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.

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.

• 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: 18814562
• MDR Text Key: 336644055
• Report Number: 0003015876-2024-00477
• 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

• 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: 003096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/01/2024
• 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