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

Model Number CRPLUS

Device Problems Power Problem (3010); Unexpected Shutdown (4019)

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

Event Date 04/01/2024

Event Type  malfunction  

Event Description

The customer contacted stryker to report a non-critical issue with their device.Upon inspection, stryker observed that their device was showing all 3 icons (charge-pak, attention and wrench) and that the device had unexpectedly lost power.As a result, defibrillation would not be available, if needed.There was no patient use associated with the reported event.

Manufacturer Narrative

Stryker performed an initial evaluation of the customer¿s device and observed that all 3 icons were illuminated (charge-pak, attention and wrench) and that the device had unexpectedly lost power.The device was deemed unrepairable, so stryker advised the customer to scrap the device.

Event Description

The customer contacted stryker to report a non-critical issue with their device.Upon inspection, stryker observed that their device was showing all 3 icons (charge-pak, attention and wrench) and that the device had unexpectedly lost power.As a result, defibrillation would not be available, if needed.There was no patient use associated with the reported event.

Manufacturer Narrative

Corrected data: section d10, returned to manufacturer on of the initial medwatch report indicates 02/04/2024; section d10, returned to manufacturer on of the initial medwatch report should indicate 04/02/2024.Additional manufacturer narrative: due to device age and being unrepairable the customer approved to scrap the device on their behalf.The device was returned to stryker product analysis center (pac) for further investigation.The pac tecnician was able to verify the reported issues.The root cause of the reported issue was determined to be isolated to bt2, part of the hybrid layer capacitor (hlc).The device was archived by stryker.

Event Description

The customer contacted stryker to report a non-critical issue with their device.Upon inspection, stryker observed that their device was showing all 3 icons (charge-pak, attention and wrench) and that the device had unexpectedly lost power.As a result, defibrillation would not be available, if needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) CR PLUS 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: 19114474
• MDR Text Key: 340692622
• Report Number: 0003015876-2024-00825
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033275
• 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,Followup,Followup
• Report Date: 05/10/2024

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: CRPLUS
• Device Catalogue Number: 99403-000211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2024
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/15/2024; 05/06/2024
• Supplement Dates FDA Received: 04/25/2024; 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2007
• 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