BEUDAMED
    FDA Adverse Event Other Summary report: N

    OHMEDA MEDICAL

    MDR report key: 509559 · Received January 13, 2004

    Report

    Report Number
    MW1030803
    Event Type
    Other
    Date Received
    January 13, 2004
    Date of Event
    December 3, 2003
    Report Date
    January 13, 2004
    Manufacturer
    GE MEDICAL/OHMEDA MEDICAL
    Product Code
    FNJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN PROCESS OF DISCHARGING PT TO FAMILY MEMBER, NURSE PLACED PT IN CAR SEAT, USING HINGED SHELF OF BASSINET CART. WHEN SHE PRESSED ON THE BELT LOCK MECHANISM TO SECURE THE PT IN THE CAR SEAT, THE BASSINET SHELF GAVE WAY AND THE CAR SEAT CONTAINING THE PT FELL 6 FEET TO THE FLOOR. THE PT DID NOT COME OUT OF THE CAR SEAT BUT POST EVENT CT SCAN REVEALED A SMALL LEFT PARIETAL CORTICAL HEMORRHAGE WITHOUT MASS EFFECT OR SKULL FRACTURE (BRAIN CONTUSION). THE PT WAS KEPT HOSPITALIZED FOR OBSERVATION BUT NEVER EXHIBITED ANY SYMPTOMS I.E., MENTAL STATUS CHANGES, SEIZURES, ETC. AT THE TIME OF THEIR DISCHARGE 5 DAYS LATER, THE HEMORRHAGE WAS STILL PRESENT BUT RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA MEDICAL WELL BABY BASSINET WITH TUB FNJ GE MEDICAL/OHMEDA MEDICAL 6600-0289-900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DAY Other