BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOLYNE DRI-BATH

    MDR report key: 72953 · Received February 28, 1997

    Report

    Report Number
    72953
    Event Type
    Injury
    Date Received
    February 28, 1997
    Date of Event
    February 18, 1997
    Report Date
    February 27, 1997
    Manufacturer
    BARNSTEAD/THERMOLYNE CORP.
    Product Code
    JRG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTING A SCREWDRIVER INTO ADJUSTMENT SCREW HOLE IN BACK OF DEVICE, AN EMPLOYEE WAS SHOCKED. WENT TO ER: ARM RED; TREATED WITH TYLENOL. IT APPEARS THAT THE SCREW DRIVER BEING USED SLIPPED OFF THE ADJUSTMENT SCREW AND TOUCHED THE INCOMING POWER CONTACT, RESULTING IN A SHOCK TO THE PT. AN ELECTRICAL SAFETY TEST WAS PERFORMED ON THE EQUIPMENT SHOWING THE GROUND WAS INTACT AND CHASSIS LEAKAGE WAS WITHIN STANDARDS. PER ENGINEER, DEVICE HAS A DESIGN FLAW, IN THAT THE ADJUSTMENT SCREW IS NOT ISOLATED FROM THE POWER CONTACT SUFFICIENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOLYNE DRI-BATH DRI-BATH USED IN BLOOD BANK JRG BARNSTEAD/THERMOLYNE CORP. DB-12215E *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization