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 Cancer (3262)

Event Date 02/29/2024

Event Type  Death  

Event Description

The customer contacted stryker to report that their device did not recognize a shockable heart rhythm.The customer advised they were monitoring a patient with a separate monitor and had the aed also attached to the patient.They alleged that the monitor showed a shockable heart rhythm, however the aed did not advise to shock.The patient did not survive.

Manufacturer Narrative

Stryker contacted the customer to request additional information on the patient.The customer provided stryker with all the available patient information.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.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.

Event Description

The customer contacted stryker to report that their device did not recognize a shockable heart rhythm.The customer advised they were monitoring a patient with a separate monitor and had the aed also attached to the patient.They alleged that the monitor showed a shockable heart rhythm, however the aed did not advise to shock.The patient did not survive.

Manufacturer Narrative

Stryker performed a clinical review of the patient event and determined it is unknown if device use contributed to the patient outcome.This was due to insufficient data within the file to determine the impact of the device use.Include rationale.No electronic file was provided to determine if the patient was in a shockable rhythm at the time of the event.

• 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: 19017716
• MDR Text Key: 339080507
• Report Number: 0003015876-2024-00661
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P170018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

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: 99512-000106
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2023
• 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: 87 YR
• Patient Sex: Female
• Patient Weight: 80 KG