BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2834292 · Received November 15, 2012

    Report

    Report Number
    1723170-2012-00638
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS PRESENT AT THE TIME. A MEDTRONIC REPRESENTATIVE, AT THE SITE, REPLACED THE FRONT LEFT CASTER ON THE SYSTEM CART ON (B)(4) 2012. RMA ISSUED. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE SYSTEM CART CASTER WAS RETURNED TO THE MANUFACTURER AND MECHANICAL INVESTIGATION FOUND THAT AS REPORTED, THE CASTER HAS BROKEN OFF AT THE BOLT.

    Description of Event or Problem · 1

    A SITE BIOMEDICAL ENGINEER REPORTED THAT THE FRONT LEFT CASTER ON THEIR STEALTHSTATION S7 SYSTEM CART BROKE OFF. IT APPEARED THAT THE THREAD ON THE WHEEL HAS BROKEN COMPLETELY. THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM, NO PATIENT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1