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

Model Number	CR2
Medical Device Problem Codes	No Audible Prompt/Feedback (2282); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted stryker to report that their device was missing its lid magnet and would not provide audio prompts.In this state, the device would not detect the lid being opened or closed, and therefore would not automatically power on or off which can lead to a use error resulting in a failure to deliver defibrillation.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The customer's device was not returned to stryker for evaluation.A customer quality engineer determined that the likely cause of the reported issue of voice prompts do not begin when the lid is opened was due to a depleted battery from the missing lid magnet.A root cause for reported issue of missing magnet in the lid could not be determined.
Event or Problem Description
A customer contacted stryker to report that their device was missing its lid magnet and would not provide audio prompts.In this state, the device would not detect the lid being opened or closed, and therefore would not automatically power on or off which can lead to a use error resulting in a failure to deliver defibrillation.Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy.There was no report of 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17929872
• Report Number: 0003015876-2023-01898
• Device Sequence Number: 6352374
• Product Code: MKJ
• UDI-Device Identifier: 00883873785911
• UDI-Public: 00883873785911
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/23/2023

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: 99512-001434
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2022
• 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