BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUUM REGULATOR

    MDR report key: 3866631 · Received June 5, 2014

    Report

    Report Number
    MW5036480
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    AMVEX CORP.
    Product Code
    KDP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REGULATOR FAILED TO PROVIDE AND DID NOT REGISTER ACCURATE SUCTION. PATIENT DID HAVE AN INCREASE IN NAUSEA PRIOR TO EQUIPMENT CHANGE, NO INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328869 VACUUM REGULATOR VACUUM REGULATOR KDP AMVEX CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR