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

Model Number CR2

Device Problems Failure to Analyze Signal (1539); No Audible Prompt/Feedback (2282)

Patient Problem Cardiac Arrest (1762)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.   a clinical review was performed and in the medical judgment of the reviewers, it is unknown if the device caused or contributed to the patient's outcome.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

The customer contacted physio-control to report that their device failed to provide audio prompts and complete an ecg analysis.The patient did not survive the event.

Event Description

The customer contacted physio-control to report that their device failed to provide audio prompts and complete an ecg analysis.The patient did not survive the event.Upon further communication with the customer they indicated no device failure occurred.

Manufacturer Narrative

The customer informed physio-control that the issue has been resolved, and the device does not need to be returned for further evaluation.Per the customer the device was operating as intended and there was no evidence of malfunction.

• 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
• MDR Report Key: 10667503
• MDR Text Key: 210987136
• Report Number: 0003015876-2020-01500
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873824139
• UDI-Public: 00883873824139
• Combination Product (y/n): N
• PMA/PMN Number: P170018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CR2
• Device Catalogue Number: 99512-001261
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 58 YR