BEUDAMED
    FDA Adverse Event Other Summary report: N

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    MDR report key: 558576 · Received November 17, 2004

    Report

    Report Number
    558576
    Event Type
    Other
    Date Received
    November 17, 2004
    Date of Event
    July 4, 2004
    Report Date
    November 17, 2004
    Manufacturer
    *
    Product Code
    KQZ
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON RETURN FROM SURGERY THE PATIENT WAS BEING MANUALLY LIFTED FROM BED ONTO ANOTHER BED WITH WEIGHTS ON HALO TRACTOR DEVICE IN PLACE AT HEAD OF BED. DR. WAS GIVING ORDERS TO LIFT PATIENT FROM THIS BED ONTO OTHER BED HOLDING PATIENT'S HEAD/NECK DURING MOVEMENT. ANOTHER DR. WAS AT SIDE OF BED HELPING LIFT PATIENT ONTO BED AS WELL AS NURSES. PATIENT'S HALO DEVICE BECAME DISLODGED OR FELL OFF OF PATIENT'S HEAD WHILE LIFTING THEIR HEAD ONTO BED AND REQUIRING FURTHER SEDATION AND NEW INSERTION OF HALO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HALO FRACTION DEVICE KQZ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *