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

Device Problem Sparking (2595)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/27/2022

Event Type  malfunction  

Event Description

While using a zoll defibrillator and zoll pads a shock was initiated that resulted in a spark that singed the patient's hair.Defibrillator was evaluated by hospital clinical engineer and zoll company.

• Brand Name: ZOLL DEFIBRILLATOR PADS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 13839513
• MDR Text Key: 287588375
• Report Number: MW5108312
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/16/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2022
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White