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

Model Number	CR2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device was missing its lid magnet.This will result in an inability of the device to detect the lid being opened or closed.In this state, a delay in defibrillation may occur, as the user has to push the power button underneath the lid to turn the device on.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
The customer received a replacement lid.The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.
Additional Manufacturer Narrative
The device's lid was returned to stryker product analysis center (pac).The pac technician was able to verify the reported issue.An evaluation of the lid found that the magnet retainer tabs were damaged, which caused the magnet to not be retained.The root cause of the reported issue was determined to be customer abuse.The device remains with the customer and the lid was archived by stryker.
Event or Problem Description
The customer contacted stryker to report that their device was missing its lid magnet.This will result in an inability of the device to detect the lid being opened or closed.In this state, a delay in defibrillation may occur, as the user has to push the power button underneath the lid to turn the device on.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) CR2 DEFIBRILLATOR
• Common Device Name: 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: 20210857
• Report Number: 0003015876-2024-02629
• Device Sequence Number: 20633717
• Product Code: MKJ
• UDI-Device Identifier: 00883873824061
• UDI-Public: 00883873824061
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P170018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-001268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown