BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLARA 3G TILT-IN-SPACE WHEELCHAIR

    MDR report key: 19079415 · Received April 10, 2024

    Report

    Report Number
    9616091-2024-00003
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 2, 2024
    Report Date
    April 10, 2024
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVACARE WAS MADE AWARE OF AN EVENT THAT OCCURRED IN SWEDEN WITH A REA AZALEA MANUAL WHEELCHAIR. THIS MEDWATCH IS BEING FILED IN AN ABUNDANCE OF CAUTION DUE TO THE SOLARA3G MANUAL WHEELCHAIR SOLD IN THE US IS OF A SIMILAR DESIGN AND WOULD LIKELY HAVE THE SAME OUTCOME AS THIS EVENT. ON THE REA AZALEA WHEELCHAIR, IT WAS NOTED THE HIP POSITIONING STRAP AND CHEST HARNESS WERE NOT PROVIDED OR MOUNTED BY INVACARE. THE HIP POSITIONING STRAP AND CHEST HARNESS ARE MANUFACTURED BY BODY POINT. THE REPORTER STATED THAT DURING INSPECTION IT WAS FOUND: THERE WERE NO DIRECT DEFECTS IDENTIFIED WITH THE WHEELCHAIR, HOWEVER, THE CHEST HARNESS AND POSITIONING BELT STRAPS WERE NOT SECURELY ATTACHED AND THEREFORE COULD SLIP AND COME LOOSE, AND THE FOOT BOX WAS OUT OF POSITION. ADDITIONAL INFORMATION WAS GATHERED. IT WAS MENTIONED THAT BEFORE THE INCIDENT THE POSITIONING BELTS AND CHEST HARNESS HAD BEEN REMOVED BY STAFF FOR CLEANING AND REINSTALLED. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE INCIDENT IS LIKELY THE RESULT OF A USE ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT SLIPPED OUT OF THE REA AZALEA MANUAL WHEELCHAIR AND OUT OF THE CHEST HARNESS. THE PATIENT BECAME TRAPPED IN THE POSITIONING BELT AND WAS FOUND HANGING FROM IT BY HIS HEAD/NECK. THE PATIENT WAS FOUND BLUE IN THE FACE AND WAS PULLED TO THE FLOOR, THE POSITIONING BELT WAS UNFASTENED. THE PATIENT EXPERIENCED CHAFING AND MARKS AND REDNESS AROUND THE NECK FROM THE POSITIONING BELT. IT IS UNCLEAR WHAT HAPPENED AS NO ONE SAW THE INCIDENT. FREQUENT INSPECTIONS TAKE PLACE WHEN THE PATIENT IS SITTING ALONE IN THE APARTMENT. ACCORDING TO THE RESIDENT STAFF, THE WHEELCHAIR WAS IN AN UPRIGHT SITTING POSITION AND BOTH THE CHEST HARNESS AND THE POSITIONING BELT WERE USED AS PRESCRIBED. IT IS UNKNOWN HOW TIGHTLY THE CHEST HARNESS WAS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135966 SOLARA 3G TILT-IN-SPACE WHEELCHAIR WHEELCHAIR, MECHANICAL IOR INVAMEX NA:SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other