BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1061845 · Received May 12, 2008

    Report

    Report Number
    3003135857-2008-00034
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Manufacturer
    *
    Product Code
    CBK
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENT WAS SENT TO THE DISTRIBUTOR FOR SERVICING FOLLOWING THIS INCIDENT. THE UNIT WAS RECEIVED AT THE DISTRIBUTOR AND THE "NO AUDIBLE ALARMS" REPORT WAS CONFIRMED. VISUAL INSPECTION CONCLUDED THAT A GREENISH LIQUID HAD LEAKED INTO THE VENT. THE ALARM ASSEMBLY WAS FOUND CORRODED AND WAS REPLACED. THE REST OF THE INSIDE OF THE VENT WAS CLEANED AND WHERE THE CORROSION WAS HEAVY, IT WAS SANDED DOWN. THE UNIT PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER. THE LIQUID IS SUSPECTED TO BE A LIQUID CLEANER USED BY THE HOSPITAL. TO AVOID LIQUID ENTERING THE VENT, LIQUID CLEANERS SHOULD BE SPRAYED ONTO A CLOTH WHICH IS THEN TO BE USED TO WIPE THE VENT CLEAN, AS EXPLAINED IN THE OPERATING MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * CBK * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *