MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number CR2

Device Problems Detachment of Device or Device Component (2907); Inappropriate or Unexpected Reset (2959)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

The customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed that the device was missing its lid magnet.In this state, the device would not detect the lid being opened or closed, and therefore would not automatically power on or off which can lead to a use error resulting in a failure to deliver defibrillation.The technician also observed that the device does not complete its boot-up cycle and constantly reboots.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.

Manufacturer Narrative

A stryker service representative performed an initial evaluation of the customer¿s device and observed that the device was missing its lid magnet and that the device does not complete its boot-up cycle and constantly reboots.Stryker further evaluated the customer¿s device at the product assessment center (pac) and verified reported issues.During visual inspection it was observed that the lid magnet was missing due to bent/stretched out magnet retaining clips, indicating the retaining clips are exposed to force.The reported issue of the rebooting of the device was isolated to user interruption of the software update.Root cause of the reported issues is determined to be user error.The customer received a replacement device.The customer's device was archived by stryker.

• Brand Name: LIFEPAK(R) CR2 DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: 18736886
• MDR Text Key: 335963151
• Report Number: 0003015876-2024-00370
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2024

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: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-000109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2020
• 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