BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCLAREN PROTON THERAPY DEVICE

    MDR report key: 11055525 · Received December 21, 2020

    Report

    Report Number
    MW5098477
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    December 17, 2020
    Manufacturer
    MCLAREN HEALTH CARE
    Product Code
    LHN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE DEVICE'S IMAGING SYSTEM ROTATED UNCONTROLLABLY AND COLLIDED WITH THE DELIVERY SYSTEM OF THE DEVICE. MY RELATIVE WAS REALLY SCARED WHEN THAT HAPPENED SINCE HE WAS ON THE TREATMENT BED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517581 MCLAREN PROTON THERAPY DEVICE SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL LHN MCLAREN HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1