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

Model Number R SERIES

Device Problem Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2021

Event Type  No Answer Provided  

Event Description

During a cardiac arrest in the ir unit where he was getting an entec placed, the zoll defibrillator sparked from the defib pads on the chest.Fda safety report id# (b)(4).

• Brand Name: ZOLL R SERIES DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 12238689
• MDR Text Key: 264064642
• Report Number: MW5102795
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R SERIES
• Device Catalogue Number: 601064903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR