BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS+

    MDR report key: 2860262 · Received November 8, 2012

    Report

    Report Number
    1217157-2012-00052
    Event Type
    Other
    Date Received
    November 8, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    KQO
    PMA / PMN Number
    K031560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WILL SUPPLY AN EXCHANGE INSTRUMENT AND REQUESTED RETURN OF INSTRUMENT FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INSTRUMENT STARTED VISIBLY SMOKING AND HAD A BURNING SMELL. CUSTOMER IMMEDIATELY UNPLUGGED THE INSTRUMENT. NO REPORT OF INJURY WITH THIS EVENT. THERE WAS NO IMPACT TO PATIENT CARE AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEK STATUS+ CT STATUS+ KQO SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1