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

Model Number CR2

Device Problem Mechanical Problem (1384)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

The customer's device was not returned to stryker for evaluation.The customer will receive replacement electrode.A cause of the reported issue could not be determined.

Event Description

The customer contacted stryker to report that their device is received with a broken seal on the electrodes.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: 18910300
• MDR Text Key: 337739500
• Report Number: 0003015876-2024-00549
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873785904
• UDI-Public: 00883873785904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170018
• 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: 03/15/2024

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: 99512-001435
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2024
• 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