BEUDAMED
    FDA Adverse Event Summary report: N

    MCLAREN PROTON THERAPY SYSTEM

    MDR report key: 11344700 · Received February 17, 2021

    Report

    Report Number
    MW5099475
    Date Received
    February 17, 2021
    Report Date
    February 15, 2021
    Manufacturer
    MCLAREN HEALTH CARE
    Product Code
    LHN
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE MCLAREN PROTON THERAPY SYSTEM DELIVERED A WRONG TREATMENT DOSE DUE TO A SOFTWARE DEFECT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237358 MCLAREN PROTON THERAPY SYSTEM SYSTEM, RADIATION THERAPY, CHARGED-PARTICLE, MEDICAL LHN MCLAREN HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1