• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIO-DETEK INCORPORATED PRO PADZ PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRO PADZ
Type of DevicePULSE-GENERATOR, PACEMAKER, EXTERNAL
Manufacturer (Section D)
BIO-DETEK INCORPORATED
269 & 271 mill road
chelmsford MA 01824
MDR Report Key9995259
MDR Text Key188833661
Report Number9995259
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
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 Received04/24/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8900-4006
Device Catalogue Number8900-4006
Device Lot Number0420A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/24/2020
Event Location No Information
Date Report to Manufacturer04/24/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/24/2020 Patient Sequence Number: 1
-
-