BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS BRAIN LAB

    MDR report key: 13692052 · Received March 7, 2022

    Report

    Report Number
    MW5107927
    Event Type
    Malfunction
    Date Received
    March 7, 2022
    Date of Event
    February 23, 2022
    Report Date
    March 4, 2022
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OLYMPUS BRAIN LAB WOULD NOT CALIBRATE PRIOR TO USE WITH PT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784622 OLYMPUS BRAIN LAB NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW BRAINLAB AG

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male