BEUDAMED
    FDA Adverse Event Death Summary report: N

    V-VAC MANUAL ASPIRATOR

    MDR report key: 982789 · Received January 23, 2008

    Report

    Report Number
    9610483-2008-00002
    Event Type
    Death
    Date Received
    January 23, 2008
    Date of Event
    October 2, 2006
    Report Date
    January 16, 2008
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    JCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS THE RESULT OF LEGAL ACTION TAKEN AGAINST MFR, THE DOCUMENTS OF WHICH ALLEGES MFR IS RESPONSIBLE FOR INJURY AND UNTIMELY DEATH TO THE PT DUE TO AN ALLEGEDLY DEFECTIVE WAC DEVICE. MFR HAS NOT RECEIVED AN INCIDENT REPORT FROM EITHER THE ENDUSER OF THE DEVICE OR THE HOSPITAL INVOLVED. NO PRODUCT HAS BEEN RETURNED OR IS EXPECTED TO BE RETURNED.

    Description of Event or Problem · 1

    INFO HAS BEEN REPORTED TO LAERDAL MEDICAL CORP BY A PLAINTIFF'S ATTORNEY ALLEGING THAT IN 2006, A FEMALE PT WAS TREATED AT HER HOME BY FIRE & RESCUE WITH CPR, VENTILATION AND SUCTION, AND WAS TRANSPORTED TO A HOSPITAL. IT IS ALSO ALLEGED THAT AN ER DOCTOR, WHILE ATTEMPTING TO INTUBATE THE PT, FOUND A RED PLASTIC OBJECT IN HER AIRWAY. THE PT DIED THAT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-VAC MANUAL ASPIRATOR MANUAL ASPIRATOR JCX LAERDAL MEDICAL A.S. V-VAC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death