BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUMANEX

    MDR report key: 511980 · Received February 13, 2004

    Report

    Report Number
    1419949-2004-00001
    Event Type
    Other
    Date Received
    February 13, 2004
    Date of Event
    February 4, 2004
    Report Date
    February 9, 2004
    Manufacturer
    VIASYS MEDSYSTEMS
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    ANESTHESIOLOGIST ATTACHED RESUSCITATOR TO ENDOTRACHEAL TUBE OF POST-OPERATIVE PT; WHEN HE SQUEEZED THE BAG, A BREATH WENT IN AND THE PT'S CHEST EXPANDED, BUT THE BREATH DID NOT EXHALE. UPON DISCONNECTION OF RESUSCITATOR TO INSPECT ENDOTRACHEAL TUBE, PT SPONTANEOUSLY EXHALED. RESUSCITATOR WAS NOT USED FURTHER. ABLE TO SUCCESSFULLY HAND VENTILATE PT WITH A SECOND RESUSCITATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMANEX MANUAL RESUSCITATOR BTM VIASYS MEDSYSTEMS NA 00704002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R