BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5546749 · Received April 5, 2016

    Report

    Report Number
    1525712-2016-00926
    Event Type
    Malfunction
    Date Received
    April 5, 2016
    Report Date
    June 16, 2016
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL/UPDATED INFORMATION WAS ADDED TO REFLECT THE DEVICE BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, THE DEVICE ISSUE WAS NOT ABLE TO BE DUPLICATED, SO THE ORIGINAL COMPLAINT ISSUE WAS NOT ABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TBM KYE CALLED ADVISED THE STABILITY LOCK SEEMS TO GET OUT OF ADJUSTMENT AND WHEN GOING DOWN RAMPS THE RIGHT OR LEFT WHEEL WILL GET STUCK UP OFF THE GROUND AND CAUSE THE CHAIR TO SWERVE RIGHT OR LEFT.

    Description of Event or Problem · 1

    (B)(6) CALLED ADVISED THE STABILITY LOCK SEEMS TO GET OUT OF ADJUSTMENT AND WHEN GOING DOWN RAMPS THE RIGHT OR LEFT WHEEL WILL GET STUCK UP OFF THE GROUND AND CAUSE THE CHAIR TO SWERVE RIGHT OR LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203799 TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET TDXSR-HD

    Patients

    Seq Age Sex Outcome Treatment
    1