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

Model Number CR2

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

The initial reporter¿s phone number is (b)(6).A stryker service representative performed an initial evaluation of the customer¿s device and observed that the device keeps resetting.The customer's device will be further evaluated at the product assessment center (pac).The customer will receive a replacement device.Stryker continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed that the device keeps resetting.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.

• 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: 18648752
• MDR Text Key: 334645322
• Report Number: 0003015876-2024-00266
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/06/2024

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: 99512-000097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2023
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2016
• 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