BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTLAB

    MDR report key: 472211 · Received July 11, 2003

    Report

    Report Number
    2246980-2003-00001
    Event Type
    Malfunction
    Date Received
    July 11, 2003
    Date of Event
    June 6, 2003
    Report Date
    July 10, 2003
    Manufacturer
    VENTLAB CORP.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT RESUSCITATED BY DEVICE VIA FACE MASK. PT THEN INTUBATED. PT VALVE OF RESUSCITATOR BROKE AT SWIVEL WHEN RESP. THERAPIST ATTEMPTED TO REMOVE MASK. DEVICE DEVELOPED LEAK AT PT VALVE WHEN SWIVEL RE-ATTACHED TO PT VALVE BY REP THERAPIST. SECOND DEVICE SUCCESSFULLY USED. PT EXPIRED. NO SUSPECTED ASSOCIATION BETWEEN CLAIMED DEVICE MALFUNCTION AND PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTLAB RESUSCITATOR BTM VENTLAB CORP. VN1000MC 3133-14

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other