MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL ONESTEP CPR COMPLETE ADULT ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 08/11/2021

Event Type  malfunction  

Event Description

Zoll onestep cpr complete adult electrodes burnt this patients chest when pads were used to cardiovert patient.Minor burns noted on chest.Fda safety report id # (b)(4).

• Brand Name: ZOLL ONESTEP CPR COMPLETE ADULT ELECTRODES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION ; chelmsford MA 01824
• MDR Report Key: 12342621
• MDR Text Key: 267624908
• Report Number: MW5103335
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 73 YR
• Patient Weight: 109