BEUDAMED
    FDA Adverse Event Other Summary report: N

    SKYTRON

    MDR report key: 483434 · Received September 11, 2003

    Report

    Report Number
    1825014-2003-00005
    Event Type
    Other
    Date Received
    September 11, 2003
    Date of Event
    July 31, 2003
    Report Date
    September 8, 2003
    Manufacturer
    SKYTRON
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PINS SNAPPED OFF OF SKYTRON TABLE ADAPTER. DOCTOR WAS HOLDING PATIENTS' HEAD WHEN DEVICE BROKE. SKYTRON CUSTOMER SERVICE REPORTED THAT THIS PROBLEM HAD OCCURRED BEFORE AND STATED THE PINS SHOULD BE MACHINED NOT STAMPED. NO ALERT WAS EVER SENT USERS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON NEURO ADAPTER TO TABLE FQO SKYTRON 7-010-01-T *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other