BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE ARM DRIVE SX5

    MDR report key: 18606500 · Received January 29, 2024

    Report

    Report Number
    MW5150867
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    January 24, 2024
    Report Date
    January 25, 2024
    Manufacturer
    INVACARE CORP.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AT 1830, RN (REGISTERED NURSE) HEARD A YELL AND COME FROM DINING ROOM. AS THIS NURSE TURNED AROUND, RESIDENT WAS FALLING OUT OF HER W/C (WHEELCHAIR), HITTING HER HEAD ON THE CORNER OF THE TABLE, SPINNING THE TABLE AROUND LANDING ON HER RIGHT SIDE. RESIDENT HIT THE RIGHT PARIETAL AREA OF HER HEAD. THE RIGHT WHEEL OF HER W/C HAD COMPLETELY FALLEN OFF RESULTING IN THE FALL. VSS (VITAL SIGNS STABLE): (TEMPERATURE) 98.2, (HEART RATE) 78, (RESPIRATORY RATE) 20, (BLOOD PRESSURE) 120/82. HEAD SHEET INITIATED, NEURO CHECKS WNL (WITHIN NORMAL LIMITS). RESIDENT HAS A HEMATOMA ON HER RUA (RIGHT UPPER ARM) & THE BEGINNING OF A SMALL HEMATOMA ON HER RIGHT HIP REGION. AT 1930, RESIDENT SAID SHE HAD TO USE THE BEDPAN. WHEN STAFF WAS ATTEMPTING TO ASSIST, RESIDENT BECAME VERY UPSET, CRYING HYSTERICALLY AND EXTREMELY AGITATED. RESIDENT THEN HAD SEIZURE-LIKE ACTIVITY LASTING 15-25 SECONDS X3 (THREE TIMES). RESIDENT WAS SENT TO THE HOSPITAL AFTER MD (MEDICAL DOCTOR) NOTIFIED AND FAMILY AGREED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551944 ONE ARM DRIVE SX5 WHEELCHAIR, MECHANICAL IOR INVACARE CORP. SX5

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization