BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KWIKLAVE AUTO CLAVE

    MDR report key: 7591 · Received January 19, 1994

    Report

    Report Number
    7591
    Event Type
    Malfunction
    Date Received
    January 19, 1994
    Date of Event
    September 10, 1993
    Report Date
    September 15, 1993
    Manufacturer
    TUTTNAUER CO. LTD
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AUTO CLAVE MACHINE WAS ON AND TECH WAS IN ANOTHER ROOM AND HEARD A NOISE LIKE A SMALL FIRE CRACKER FROM THE ROOM THE AUTO CLAVE WAS IN. WHEN SHE WENT IN TO THE ROOM THE POWER LIGHT WAS ON AND ALL OTHER LIGHTS WERE OFF - PRESSURE WAS DOWN. SHE TURNED OFF THE POWER AND OPENED THE AUTO CLAVE DOOR TO EXAMINE THE CASSETTES, THE CASSETTES WERE OK BUT NOT STERLIZIED. COMPANY WAS CALLED AND CAME AND TOOK MACHINE. WE WERE GIVEN A RENTAL UNTIL IT COULD BE REPLACED.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-93. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KWIKLAVE AUTO CLAVE STERILIZER FLE TUTTNAUER CO. LTD 2540 MK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other