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

Model Number CR2

Device Problem Failure to Sense (1559)

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

Event Date 03/12/2023

Event Type  Death  

Event Description

The customer contacted stryker to report that their device would not detect the patient through the defibrillation electrodes.In this state the device would not be able to deliver defibrillation therapy if needed.The patient involved in the reported event is deceased; however, the customer advised stryker that the device use did not contribute to the outcome of the patient.

Manufacturer Narrative

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.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.

Event Description

The customer contacted stryker to report that their device would not detect the patient through the defibrillation electrodes.In this state the device would not be able to deliver defibrillation therapy if needed.The patient involved in the reported event is deceased; however, the customer advised stryker that the device use did not contribute to the outcome of the patient.

Manufacturer Narrative

The device was returned to stryker for evaluation.The reported issue was verified but not able to be duplicated.The electrodes used during the event were not returned.The device worked as expected during testing.The device was archived by stryker.The cause of the reported issue could not be determined.

• Brand Name: LIFEPAK® 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16702173
• MDR Text Key: 312892468
• Report Number: 0003015876-2023-00643
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873824139
• UDI-Public: 00883873824139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160026
• 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,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-001261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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
• Patient Outcome(s): Death
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: Black Or African American