BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2873069 · Received December 13, 2012

    Report

    Report Number
    9616091-2012-00641
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL T93HC, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY THREE MONTH OLD. THE CONSUMER WEIGHT IS (B)(6). HOWEVER, AGE AND HEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE INCORRECT INFORMATION WAS PROVIDED ON THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    (B)(4). THE DEALER REPORTED THAT THE T93HC MECHANICAL WHEELCHAIR FRONT RIGGINGS WERE BROKEN. THE PATIENT WEIGHT IS (B)(6). THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other