BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCM STERILIZER

    MDR report key: 249511 · Received November 11, 1999

    Report

    Report Number
    1017522-1999-00117
    Event Type
    Malfunction
    Date Received
    November 11, 1999
    Date of Event
    October 13, 1999
    Report Date
    November 11, 1999
    Manufacturer
    PELTON & CRANE, A DCI CO.
    Product Code
    FLE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SERVICE REP INFORMED PELTON & CRANE OF AN INCIDENT INVOLVING A 16 1/2 YEAR OLD OCM STERILIZER OF WHICH THE DOOR BLEW OPEN UNDER PRESSURE. THE DOCTOR'S OFFICE TOLD HIM THAT THEY HEARD A LOUD NOISE AND WENT INTO THE ROOM WHERE THE STERILIZER IS LOCATED AND FOUND THE DOOR AJAR. 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 OCM STERILIZER STEAM STERILIZER FLE PELTON & CRANE, A DCI CO. A3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA