BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M51P RED BASE W/MK5 NX SPJ+ 9153642088

    MDR report key: 4894280 · Received July 7, 2015

    Report

    Report Number
    3008262382-2015-01452
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Report Date
    June 10, 2015
    Manufacturer
    INVACARE REHABILITATION EQUIPMENT CO.
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    THE DEALER STATE THAT THE BOLT HOLDING THE SEAT IS SHEARING THE SEAT POLE. THE DEALER STATED THAT THIS ALLOWS THE SEAT TO ROTATE IN A FULL CIRCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439135 M51P RED BASE W/MK5 NX SPJ+ 9153642088 WHEELCHAIR, POWERED ITI INVACARE REHABILITATION EQUIPMENT CO. M51PSR20R

    Patients

    Seq Age Sex Outcome Treatment
    1 74 Other