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	03/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker for evaluation.The customer will be provided with a replacement lid.A cause of the reported issue could not be determined.H3 other text : device not returned.
Event or Problem Description
The customer contacted stryker to report that the magnet was missing from the lid of their device.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
Section b5 executive summary of initial mdr indicates: the customer contacted stryker to report that the magnet was missing from the lid of their device.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.Section b5 executive summary of initial mdr should indicate: the customer contacted stryker to report a non-critical issue with their device.Upon evaluation, stryker observed that the magnet was missing from the lid of their device.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.Section d9 product available to stryker of initial mdr indicates: no section d9 product available to stryker of initial mdr should indicate: return section d9 returned to manufacturer on of initial mdr indicates: blank section d9 returned to manufacturer on of initial mdr should indicate: 03/08/2024 section h3 device evaluated by mfg of initial mdr indicates: no section h3 device evaluated by mfg of initial mdr should indicate: yes section h11 additional mfg narrative of initial mdr indicates: the device was not returned to stryker for evaluation.The customer will be provided with a replacement lid.A cause of the reported issue could not be determined.Section h11 additional mfg narrative of initial mdr should indicate: stryker evaluated the customer's device and observed that the magnet was missing from the lid of their device.After replacing the lid, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.Upon evaluation, stryker observed that the magnet was missing from the lid of their device.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: 18956572
• Report Number: 0003015876-2024-00604
• Device Sequence Number: 18482866
• Product Code: MKJ
• UDI-Device Identifier: 00883873824115
• UDI-Public: 00883873824115
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/20/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-001263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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