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

Model Number CR2

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Cardiac Arrest (1762); Coma (2417)

Event Date 06/20/2021

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Though physio-control requested some patient information, physio will not request any information which can identify, directly or indirectly, a person to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Physio-control contacted the customer in order to obtain additional information about the device and event; however, no additional information was provided.Physio-control 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

A customer contacted physio-control to report that their device failed to deliver shock during intervention on a patient.This issue is patient related it was reported there was a delay to defibrillation.After an unknown delay a back up device arrived and the patient was provided defibrillation.The patient was successfully resuscitated and at the time of report was in a comatose state.

Event Description

A customer contacted physio-control to report that their device failed to deliver shock during intervention on a patient.This issue is patient related it was reported there was a delay to defibrillation.After an unknown delay a back up device arrived and the patient was provided defibrillation.The patient was successfully resuscitated and at the time of report was in a comatose state.

Manufacturer Narrative

The customer was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to stryker for evaluation.The reported issue could not be verified and the cause of the reported issue could not be determined.A clinical review of the reported event was performed by the sme and it was determined that the delay in care may have prolonged the time the patient was in a hypoxic state, potentially contributing to the coma (vegetative state).

• Brand Name: LIFEPAK(R) 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: 12184587
• MDR Text Key: 262164873
• Report Number: 0003015876-2021-01422
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/08/2022

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: UNK_MED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other