BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMICLAVE

    MDR report key: 27061 · Received October 6, 1995

    Report

    Report Number
    MW4000832
    Event Type
    Malfunction
    Date Received
    October 6, 1995
    Date of Event
    March 10, 1995
    Report Date
    March 20, 1995
    Manufacturer
    MDT BIO/MDT DIV.
    Product Code
    MLR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 3/10/95 A DENTAL TECH NOTICED SMOKE COMING FROM THE UNIT. FIRE DEPT WAS CALLED & RESPONDED. WHILE AWAITING THE ARRIVAL OF THE FIRE DEPT THE UNIT WAS UNPLUGGED & THE SMOKE DISSIPATED. AN INVESTIGATION BY THE LOCAL BIO-MEDICAL EQUIPMENT REPAIR WORK CENTER REVEALED THAT THE SMOKE WAS CAUSED BY A SOLID STATE RELAY ON THE I/O PRINTED CIRCUIT BOARD THAT OVERHEATED & CAUGHT FIRE. THE UNIT'S CIRCUIT BREAKER & FUSES DID NOT TRIP OR BLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMICLAVE CHEMICLAVE MLR MDT BIO/MDT DIV. 8000D

    Patients

    Seq Age Sex Outcome Treatment
    1 *