BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1180566 · Received June 30, 2008

    Report

    Report Number
    3003135857-2008-00041
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Manufacturer
    FLIGHT MEDICAL LTD.
    Product Code
    CBK
    PMA / PMN Number
    k992133
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: EXAMINATION OF THIS VENTILATOR FOUND THE AIR INLET FILTER WAS VERY DIRTY ON BOTH SIDES OF THE FILTER. IN ADDITION, METALLIC DEBRIS WAS FOUND ON THE FILTER AND AT THE O-RING FROM THE MIXER USED WITH THE VENTILATOR. THE SOURCE FOR THIS METALLIC DEBRIS IS DUE TO HOSPITAL USING AN OLD OXYGEN TANK THAT CONTAINED METALLIC DEBRIS WITH THIS VENTILATOR. THE LABELING FOR THIS VENTILATOR ON THE FILTER COVER HOUSING, THE USER MANUAL, AND THE SVC MANUAL ALL HAVE INSTRUCTIONS DIRECTING THE USER TO NOT RE-USE OR REVERSE THE FILTER AS WELL AS TO INSPECT THE FILTER WEEKLY AND REPLACE WITH A NEW FILTER WHEN DIRTY. THE MFR: FLIGHT MEDICAL LTD, HAS BEEN NOTIFIED OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * CBK FLIGHT MEDICAL LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1