MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL PRO-PADZ ADULT MULTIFUNCTION-ELE; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 8900-4006

Device Problem Excessive Heating (4030)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 02/02/2021

Event Type  Injury  

Event Description

Cardioversion performed.Patient shocked through defib pads twice (120j and 200j).Upon removal of defib pads first degree burn observed.Fda safety report id # (b)(4).

• Brand Name: ZOLL PRO-PADZ ADULT MULTIFUNCTION-ELE
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION ; chelsford MA 01824 4105
• MDR Report Key: 11292914
• MDR Text Key: 230987275
• Report Number: MW5099264
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661(17)220123(10)
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Model Number: 8900-4006
• Device Lot Number: 0421B
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Age: 57 YR