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

Model Number 30001005201310012

Patient Problem Burn(s) (1757)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

Patient undergoing cardioversion with zoll equipment.After shock was delivered to patient, there was a pop sound and a burning smell.Patient did not convert, so pads were removed exposing burns on chest and upper back of patient.New pads attached another conversion attempted.Same pop sound and burn smell.Patient converted, when pads removed patient had additional burns to anterior chest.

• Brand Name: R SERIES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 18676893
• MDR Text Key: 335019830
• Report Number: 18676893
• 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: 12/14/2023

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
• Device Model Number: 30001005201310012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2023
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 52 KG
• Patient Race: Asian