BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTLAB V CARE ADULT RESUSCITATOR

    MDR report key: 1674851 · Received April 29, 2010

    Report

    Report Number
    2246980-2010-00001
    Event Type
    Injury
    Date Received
    April 29, 2010
    Report Date
    April 29, 2010
    Manufacturer
    VENTLAB CORP.
    Product Code
    BTM
    PMA / PMN Number
    K012842
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FITSALL CONNECTOR OF THE RETURNED RESUSCITATOR HAD BECOME SEPARATED FROM THE TUBING. THERE IS EVIDENCE OF BONDING ON THE TUBING. IT REMAINS INCONCLUSIVE AS TO THE CAUSE OF THE TUBING/CONNECTOR SEPARATION. A CORRECTIVE ACTION FILE (CAPA) TO INVESTIGATE THE ROOT CAUSE OF THE SEPARATION HAS BEEN INITIATED AND CURRENTLY IS ON-GOING. PHOTOS OF THE END OF THE TUBING ALONG WITH THE CONNECTOR IS ATTACHED FOR VISUAL INTERPRETATION.

    Description of Event or Problem · 1

    THE BAG WAS USED BY AN ANESTHESIA DOCTOR FOR TRANSPORTING A PATIENT AND THE OXYGEN TUBING BECAME DISCONNECTED FROM THE RED END CONNECTOR AND THE PATIENT DESATURATED DOWN TO 70%. THE MD WAS ABLE TO BRING THE PATIENT'S SATURATION BACK UP TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTLAB V CARE ADULT RESUSCITATOR EMERGENCY MANUAL RESUSCITATOR BTM VENTLAB CORP. VN 1000 SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention