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

Model Number	CR2
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker performed an initial evaluation of the customer's device and observed that the device would not deliver defibrillation energy.The customer will receive a replacement device.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted stryker to report that their device made a loud pop.Upon investigation it was found the device would not deliver defibrillation energy.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient involvement reported with the event.
Additional Manufacturer Narrative
Further investigation of the device found multiple components affected by electrical overstress, the h-bridge fets, q71, q72 and q74 were affected.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device made a loud pop.Upon investigation it was found the device would not deliver defibrillation energy.In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient involvement reported with the event.

• Brand Name: LIFEPAK® 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: 17973295
• Report Number: 0003015876-2023-01942
• Device Sequence Number: 14707557
• Product Code: MKJ
• UDI-Device Identifier: 00883873824085
• UDI-Public: 00883873824085
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/27/2023

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: 99512-001266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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