BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIVATORS

    MDR report key: 2033053 · Received March 30, 2011

    Report

    Report Number
    2150060-2011-00017
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED BY A MINNTECH FIELD SERVICE ENGINEER. IT APPEARS TWO RESISTORS CAUSED A MINOR FIRE WITH SMOKE EMITTING FROM THE PRINTER. DEVICE HAS BEEN SERVICED BY (B)(4) IN THE PAST AND SERVICE RECORDS ARE UNAVAILABLE. SUSPECT PART WAS A REPLACEMENT OF ORIGINAL PRINTER. THIS SITUATION HAS BEEN DETERMINED TO BE AN ISOLATED INCIDENT. A THOROUGH INSPECTION OF THE MACHINE HAS BEEN COMPLETED AND MACHINE IS FULLY OPERATIONAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTS SMOKE EMITTING FROM PRINTER. NO PATIENT INVOLVEMENT. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIVATORS ENDOSCOPE DISINFECTOR FEB MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH DSD-2001

    Patients

    Seq Age Sex Outcome Treatment
    1