MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION PRO PADZ; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 8900-4006

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/30/2023

Event Type  malfunction  

Event Description

Patient was cardioverted and at the time of the shock there was an audible crack/spark that was heard.Initially, no evidence of injury, but then smelled smoke/burning.The anterior zoll pad was removed and we noted a skin burn on the patient.There is evidence of burn on the pad at the same location as on the skin.

• Brand Name: PRO PADZ
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 18418040
• MDR Text Key: 331587386
• Report Number: 18418040
• Device Sequence Number: 1
• Product Code: DTE
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8900-4006
• Device Catalogue Number: 89004006
• Device Lot Number: 3823A
• 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: 12/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2023
• 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: 22630 DA
• Patient Sex: Male
• Patient Race: White