BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPR-2

    MDR report key: 2800915 · Received October 12, 2012

    Report

    Report Number
    2800915
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    August 8, 2012
    Report Date
    October 12, 2012
    Manufacturer
    MERCURY MEDICAL
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE VENTILATING PATIENT PRIOR TO INTUBATION UTILIZING MERCURY MEDICAL CPR 2 RESUSCITATION BAG, THE OXYGEN TUBING CONNECTED TO BAG BECAME KINKED, WHICH OCCLUDED FLOW OF OXYGEN TO THE DEVICE. PATIENT O2 SATURATION CONTINUED TO DROP, SO A NEW BAG WAS SUBSTITUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPR-2 VENTILATOR, EMERGENCY, MANUAL BTM MERCURY MEDICAL * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR