MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 8900-4006

Device Problem Arcing (2583)

Patient Problem Burn, Thermal (2530)

Event Date 03/03/2020

Event Type  malfunction  

Event Description

Defibrillator pad arced during cardioversion causing minor burn to patient.

• Brand Name: PRO PADZ
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 269 & 271 mill road; chelmsford MA 01824
• MDR Report Key: 9995259
• MDR Text Key: 188833661
• Report Number: 9995259
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 03/24/2020,03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 0420A
• 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: 03/24/2020
• Date Report to Manufacturer: 04/24/2020
• 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: 24455 DA