BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABER DRYER

    MDR report key: 11552373 · Received March 22, 2021

    Report

    Report Number
    MW5100162
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 18, 2021
    Manufacturer
    STABER INDUSTRIES, INC.
    Product Code
    JRJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STABER DRYER USED IN CME AREA OF HOSPITAL MALFUNCTIONED RESULTING IN MELTING OF PARTS AND SMOKE IN DEPARTMENT. PRELIMINARY INVESTIGATION INDICATES THAT SAFETY MECHANISM FOR OVER HEATING FAILED. ALLOWING THE DRYER TO BECOME TOO HOT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445012 STABER DRYER UNIT, DRYING JRJ STABER INDUSTRIES, INC. IDC2201

    Patients

    Seq Age Sex Outcome Treatment
    1