MAUDE Adverse Event Report: ZOLL MEDICAL CORP. DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number R-SERIES

Device Problem No Display/Image (1183)

Patient Problems Coma (2417); Confusion/ Disorientation (2553); Loss Of Pulse (2562)

Event Date 10/01/2019

Event Type  Injury  

Event Description

At 0941 found pulseless and unresponsive.Code blue called.Defibrillator and pads applied.No display available on monitor.Second defibrillator attached to pads and monitor showed asystole.Prior to code, pt confused.After code coma.Cold calorics consistent with brain death.

• Brand Name: DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORP. ; 269 mill rd. ; chelmsford MA 01824
• MDR Report Key: 9180036
• MDR Text Key: 162343105
• Report Number: MW5090351
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/03/2019

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: No Information
• Device Model Number: R-SERIES
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 60 YR
• Patient Weight: 53