MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL PRO PADZ (PACE AND DEFIB PADS); AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number PACKAGING WAS NOT SAVED

Device Problem Excessive Heating (4030)

Patient Problem Burn, Thermal (2530)

Event Date 12/23/2020

Event Type  Injury  

Event Description

Defibrillation performed with zoll pro padz and patient received burn to anterior chest wall.Fda safety report id# (b)(4).

• Brand Name: ZOLL PRO PADZ (PACE AND DEFIB PADS)
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 11108055
• MDR Text Key: 225091540
• Report Number: MW5098623
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PACKAGING WAS NOT SAVED
• 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 Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 74