BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIDATOR 10

    MDR report key: 273566 · Received April 13, 2000

    Report

    Report Number
    1017522-2000-00027
    Event Type
    Malfunction
    Date Received
    April 13, 2000
    Date of Event
    March 14, 2000
    Report Date
    April 13, 2000
    Manufacturer
    PELTON & CRANE, A DCI CO
    Product Code
    FLE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SERVICE REP INFORMED PELTON & CRANE OF AN INCIDENT INVOLVING AN 11 AND 1/2-YEAR-OLD VALIDATOR 10 STERILIZER. THE SERVICE REP ALLEGEDLY CLAIMS THE DOOR BLEW OPEN UNDER PRESSURE. THE DOCTOR'S OFFICE TOLD THE SERVICE REP THAT THEY HEARD A LOUD NOISE AND WENT INTO THE ROOM WHERE THE STERILIZER WAS LOCATED AND FOUND THE STERILIZER LYING ON THE FLOOR. THE INSTRUMENTS THAT WERE INSIDE THE STERILIZER CHAMBER WERE SCATTERED ACROSS THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIDATOR 10 STEAM STERILIZER FLE PELTON & CRANE, A DCI CO AA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA