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

Model Number CR2

Device Problem Failure to Analyze Signal (1539)

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

Event Date 03/19/2024

Event Type  malfunction  

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.Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.

Event Description

The customer contacted stryker to report that their device advised a shock when not appropriate.In this state the device may deliver inappropriate defibrillation therapy if needed.The patient involved did not survive, however there was no adverse event reported.

• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 19093510
• MDR Text Key: 340684266
• Report Number: 0003015876-2024-00759
• 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: P170018
• 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
• Report Date: 04/11/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-001261
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2021
• 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