BEUDAMED
    FDA Adverse Event Death Summary report: N

    TILT IN SPACE

    MDR report key: 9592326 · Received January 15, 2020

    Report

    Report Number
    1531186-2020-00005
    Event Type
    Death
    Date Received
    January 15, 2020
    Report Date
    December 16, 2019
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RECORD IS BEING FILED IN AN ABUNDANCE OF CAUTION. AT THE TIME OF THIS FILING, NO MALFUNCTIONS OR DEFICIENCIES HAVE BEEN ALLEGED. INVACARE WAS MADE AWARE OF THIS EVENT THAT OCCURRED IN THE (B)(6) WITH A REA AZALEA WHEELCHAIR. THIS RECORD WAS CREATED DUE TO THE U S. MANUFACTURED SOLARA 3G BEING SIMILAR IN DESIGN AND WOULD LIKELY TO HAVE THE SAME ADVERSE OUTCOME AS THIS EVENT. INVACARE DOES NOT KNOW THE AGE OF THE DEVICE, SO THE MANUFACTURING FACILITY IS UNKNOWN. THE SOLARA 3G, WAS AT ONE TIME MANUFACTURED AT INVACARE (B)(4), AND THEN MANUFACTURING WAS MOVED TO INVAMEX, THE REA AZALEA HAS NOT BEEN RETURNED TO INVACARE (B)(4) FOR AN EVALUATION. IF MORE INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    INVACARE WAS NOTIFIED A PATIENT HAS DIED WHILE IN THE REA AZALEA WHEELCHAIR, IN WHAT WE BELIEVE IS A CIGARETTE RELATED FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55044 TILT IN SPACE WHEELCHAIR, MECHANICAL IOR NA:SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Death