BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTLE

    MDR report key: 110584 · Received July 11, 1997

    Report

    Report Number
    110584
    Event Type
    Malfunction
    Date Received
    July 11, 1997
    Date of Event
    June 4, 1997
    Report Date
    July 3, 1997
    Manufacturer
    GETINGE-CASTLE
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AUTOCLAVE WOULD NOT OPEN DURING A PT'S SURGICAL PROCEDURE. NEEDED INSTRUMENTS IN THE AUTOCLAVE. THE COMPANY REP HAD BEEN HERE TWO TIMES AND THE LAST TIME HE TOLD PLANT SERVICES TO ORDER A PART. THE PART WASN'T IN CO'S FACILITY AT THE TIME OF THE INCIDENT. THIS HAD OCCURRED MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE AUTOCLAVE FLE GETINGE-CASTLE 3120 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other