BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIDATOR 8

    MDR report key: 137036 · Received December 8, 1997

    Report

    Report Number
    1017522-1997-00133
    Event Type
    Malfunction
    Date Received
    December 8, 1997
    Report Date
    December 5, 1997
    Manufacturer
    SIEMENS PELTON & CRANE CO.
    Product Code
    FLE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DOCTOR'S OFFICE THAT THE DOOR CAME OPEN ON A VALIDATOR 8 STERILIZER DURING A STERILIZING CYCLE. THE DOCTOR CLAIMS THAT THEY HEARD AN EXPLOSION AND WENT TO THE ROOM WHERE THE STERILIZER WAS AND FOUND THE STERILIZER'S DOOR OPEN. THEY ALSO FOUND THE INSTRUMENTS THAT WERE INSIDE THE STERILIZER ACROSS THE ROOM ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIDATOR 8 STEAM STERILIZER FLE SIEMENS PELTON & CRANE CO. AB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA