BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX

    MDR report key: 5191729 · Received October 30, 2015

    Report

    Report Number
    1525712-2015-05129
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Report Date
    October 8, 2015
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    RECORD 1 OF 2. PROVIDER ADVISED TECH SERVICES THAT THE CONSUMER TOOK THE GAS CYLINDERS OFF OF THE CHAIR THEMSELVES AND HAVE BEEN THROWN OUT OF THE CHAIR TWICE. PROVIDER HUNG UP BEFORE ANY ADDITIONAL COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722503 TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX WHEELCHAIR, POWERED ITI INVACARE TDXSIV-HD

    Patients

    Seq Age Sex Outcome Treatment
    1