BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEIMICH CHEST DRAIN VALVE

    MDR report key: 134642 · Received November 24, 1997

    Report

    Report Number
    1313807-1997-00002
    Event Type
    Death
    Date Received
    November 24, 1997
    Date of Event
    October 24, 1997
    Report Date
    November 21, 1997
    Manufacturer
    BECTON DICKINSON AND CO. BECTON DICKINSON DIV.
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 10/24/97 IT WAS REPORTED THAT THE PT DIED WITH A HEIMLICH CHEST DRAIN VALVE IN PLACE. THE VALVE WAS REPORTED TO HAVE BEEN PLACED BACKWARDS. THE FACILITY BELIEVES THAT THE VALVE HAD COME LOOSE DURING THE NIGHT AND SOMEONE CARING FOR THE PT REPLACED IT BACKWARDS. APPARENTLY NO ONE OBSERVED THAT THE PT HAD ANY DIFFICULTY BREATHING OR WAS OTHERWISE IN DISTRESS. THE PT HAD NO ELECTRONIC MONITORING IN PLACE AT THE TIME OF THE INCIDENT, NO PULSE OXIMETER, NO EKG. THE PT WAS BREATHING ROOM AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEIMICH CHEST DRAIN VALVE CHEST DRAIN VALVE KDQ BECTON DICKINSON AND CO. BECTON DICKINSON DIV. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death