BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRRUS HD OCT

    MDR report key: 3193180 · Received June 25, 2013

    Report

    Report Number
    2918630-2013-00001
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 25, 2013
    Manufacturer
    CARL ZEISS MEDITEC, INC.
    Product Code
    HLI
    PMA / PMN Number
    K111157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE, WHICH WAS RETURNED TO THE MANUFACTURER, UNDERWENT AN ANALYSIS OF POSSIBLE FAILURE MODES AT A THIRD-PARTY LAB. THE LAB DETERMINED THAT A TANTALUM CAPACITOR FAILED AND DISCHARGED A SMALL EXTREME TEMPERATURE PARTICLE THAT LODGED IN THE INSULATION OF A CABLE. THE INSULATION OF THE CABLE ACTED AS FUEL FOR THE RESULTING FIRE. (B)(4). SITE CONTACT: SAME AS INITIAL REPORTER.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT BETWEEN PT EXAMINATIONS WITH THE CIRRUS HD-OCT 4000, HE OBSERVED THAT THE INSTRUMENT WAS EMITTING WHITE SMOKE AND THE DISPLAY SCREEN WAS BLANK. HE IMMEDIATELY UNPLUGGED THE POWER CABLE AND COVERED THE INSTRUMENT WITH A FIRE BLANKET. HE SUBSEQUENTLY REMOVED THE FIRE BLANKET AND FOUND THAT ONE OF THE INSTRUMENT COVERS HAD BEEN DEFORMED AND FLAMES WERE VISIBLE. HE USED A FOAM FIRE EXTINGUISHER TO PUT OUT THE FIRE. IT WAS REPORTED THAT THERE WERE NO INJURIES AND THE FIRE WAS CONFINED TO THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287238 CIRRUS HD OCT OPHTHALMOSCOPE, AC-POWERED HLI CARL ZEISS MEDITEC, INC. 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1