BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M5 CORPUS

    MDR report key: 9417638 · Received December 4, 2019

    Report

    Report Number
    MW5091453
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    March 1, 2019
    Report Date
    December 2, 2019
    Manufacturer
    PERMOBIL, INC.
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SO I GOT MY PERMOBIL M5 WHEELCHAIR SERIAL NUMBER (B)(4), (B)(6) 2018. AND IT¿S BEEN DEFECTIVE PRETTY MUCH EVER SINCE I GOT IT. THERE¿S BEEN A CLICKING/ GRINDING NOISE COMING FROM THE RIGHT AND LEFT SIDE. THERE¿S BEEN UNEVEN TIRE WEAR ON ALL THE TIRES INCLUDING THE DRIVE TIRES. THERE¿S BEEN A LOT OF ERRORS I'VE GOTTEN, THE CHAIR WILL DISPLAY A SPEED EVEN THOUGH I'M AT A DEAD STOP, THERE¿S BEEN ABNORMAL NOISES COMING FROM THE TILT/ SEAT LIFT ACTUATOR MOTOR. I'VE BEEN TO AIRWAY OXYGEN SEVERAL TIMES THEY'RE GETTING SICK OF IT, PERMOBIL JUST KEEPS THROWING PARTS AT THIS CHAIR WITH NO RESOLUTION TO IT. FOR A (B)(6) CHAIR RETAIL THIS CHAIR SHOULDN'T BE HAVING THIS MANY PROBLEMS. I CAN EXPLAIN MORE ON A PHONE CALL. I ALSO HAVE WAY MORE PICTURES BUT CAN ONLY UPLOAD 8 MB. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208739 M5 CORPUS WHELLCHAIR, POWERED ITI PERMOBIL, INC. M5 MID WHEEL DRIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other