MAUDE Adverse Event Report:; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Device Problem Failure to Capture (1081)

Patient Problems Death (1802); Electro-Mechanical Dissociation (1826)

Event Date 01/06/2021

Event Type  Death  

Event Description

Patient found to not have pulse, so code blue initiated.Rental defibrillator was connected to patient and all wires were on correctly, but it was not capturing a rhythm and only showed dotted lines on the monitor.Another defibrillator was obtained and connected to patient which worked and showed pea.The patient had an aicd so that was firing so this equipment malfunction did not contribute to the demise of the patient but has high potential for others.This was taken out of service and given to biomed.

• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• MDR Report Key: 11342586
• MDR Text Key: 232351722
• Report Number: 11342586
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2021

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: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 26645 DA
• Patient Weight: 67