BEUDAMED
    FDA Adverse Event Death Summary report: N

    VEGA 505EE

    MDR report key: 9417291 · Received December 5, 2019

    Report

    Report Number
    3009481053-2019-00046
    Event Type
    Death
    Date Received
    December 5, 2019
    Date of Event
    October 20, 2019
    Report Date
    December 3, 2019
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS TRANSFERRED FROM WHEEL CHAIR AND BED. COMPONENT ATTACHING SLINGBAR TO VEGA FLOOR LIFT DETACHED AND PATIENT FELL TO THE FLOOR. PATIENT SUSTAINED SERIOUS NECK INJURIES AND BRAIN HEMORRHAGE. MANUFACTURER WAS NOTIFIED ABOUT THE INJURIES ON (B)(6) AND LATER ON (B)(6) WAS NOTIFIED ABOUT THE DEATH OF PATIENT. MANUFACTURER INITIATED AN INTERNAL INVESTIGATION ON THE INCIDENT.

    Description of Event or Problem · 1

    SLING BAR DETACHED FROM LIFT AND PATIENT FELL TO THE FLOOR CAUSING SERIOUS INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212604 VEGA 505EE PATIENT LIFTS FSA HANDICARE AB 60600003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L