BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLARA 3G LTD 20W 24 COM 9153653250

    MDR report key: 5716869 · Received June 10, 2016

    Report

    Report Number
    1525712-2016-01903
    Event Type
    Malfunction
    Date Received
    June 10, 2016
    Report Date
    June 1, 2016
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCKING GAS CYLINDER BROKE CAUSING THE BACKREST TO RECLINE AND THE PATIENT COULD NOT GET OUT ON THEIR OWN. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE LOCKING GAS CYLINDER BROKE CAUSING THE BACKREST TO RECLINE AND THE PATIENT COULD NOT GET OUT ON THEIR OWN. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371045 SOLARA 3G LTD 20W 24 COM 9153653250 WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET SOLARA 3G

    Patients

    Seq Age Sex Outcome Treatment
    1