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

Model Number 8900-4006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Burn noted on skin of chest after synchronized cardioversion.Cath lab uses non- radiolucent pro-padz defib pads ref- 8900-4006.It appeared that the inner ring of left circular burn ring on patient.

• Brand Name: PRO PADZ
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park dr; pawtucket RI 02861
• MDR Report Key: 9853293
• MDR Text Key: 184126780
• Report Number: 9853293
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2020

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
• Device Operator: Other
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA