BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSVENT

    MDR report key: 1912979 · Received November 18, 2010

    Report

    Report Number
    1218704-2010-00012
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BIO-MED DEVICES, INC.
    Product Code
    CBK
    PMA / PMN Number
    K942938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DID EXTENSIVE TESTING AND OBSERVATION ON THIS UNIT, INCLUDING VIBRATION, AND HIGH - AND LOW - HEAT TESTING. COULD NOT EVER STIMULATE THE REPORTED DYNAMIC. FULL MECHANICAL AND ELECTRICAL EVAL WAS PERFORMED. DEVICE WILL BE RETURNED TO THE USER AFTER STANDARD CALIBRATION DOCUMENTATION. NO CORRECTIVE ACTION.

    Description of Event or Problem · 1

    TRANSPORT VENTILATOR "STOPPED CYCLING" ON A PT (IT DID ALARM - NO INJURY TO PT - ASSUMEDLY BACKUP VENTILATION WAS USED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSVENT CV-4+ CBK BIO-MED DEVICES, INC. 4400 AEC

    Patients

    Seq Age Sex Outcome Treatment
    1