MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Device Problems Failure to Power Up (1476); Battery Problem (2885)

Patient Problem Asystole (4442)

Event Date 11/06/2022

Event Type  malfunction  

Event Description

The patient went into asystole/cardiac arrest.The code cart was pulled into the room and the zoll was turned on but would not stay on more than one or two seconds.Attempted twice.Another zoll machine was already in the room from a previous arrest and was working normally, so no harm occurred.There was a green check on the zoll and no indication of low battery on the front panel.After the event, the zoll was plugged back in and worked normally, but turned off again when unplugged.When the battery test button was pushed, it lit up over the "?" icon.

• Brand Name: DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 16408849
• MDR Text Key: 309904389
• Report Number: 16408849
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9125 DA
• Patient Sex: Male