BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CESAR/C-STANDFLOOR-OMCP-VISUB-CCD (V5000)

    MDR report key: 2002528 · Received January 28, 2011

    Report

    Report Number
    3003768277-2011-00071
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Report Date
    December 29, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K984545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION FOUND THAT THERE WAS NO FIRE OR SMOKE, JUST A BURNING ODOR. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THERE WERE FOUR ISSUES WITH THE SYSTEM: THE POWER SUPPLY HAD A BROKEN CAPACITOR AND WAS REPLACED, ONE OF THE FOUR FANS RESPONSIBLE FOR COOLING THAT AREA OF THE CABINET WAS NOT WORKING AND WAS REPLACED. THE FSE INDICATED THAT, THAT WAS THE AREA OF THE CABINET WHERE THE ODOR WAS COMING FROM. THERE WAS A FAN IN THE POWER SUPPLY NEW VISUB THAT WAS NOT WORKING AND WAS REPLACED. WHEN THE FSE SWITCHED ON THE POWER SUPPLY VISUB, THE RELAY DID NOT START AND WAS REPLACED. AFTER THE PARTS WERE REPLACED IN THE SYSTEM, THE REPORTED ISSUES WERE RESOLVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A STRONG BURNING ODOR COMING FROM THE SISCO CABINET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CESAR/C-STANDFLOOR-OMCP-VISUB-CCD (V5000) IZI PHILIPS HEALTHCARE 72248

    Patients

    Seq Age Sex Outcome Treatment
    1