BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISION CENTRAL STATION

    MDR report key: 628523 · Received August 18, 2005

    Report

    Report Number
    1051786-2005-00007
    Event Type
    Other
    Date Received
    August 18, 2005
    Date of Event
    July 19, 2005
    Report Date
    August 18, 2005
    Manufacturer
    INVIVO CORPORATION
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT WAS SITTING NEXT TO THE VISION CENTRAL STATION WITH THEIR ARM EXTENDED OUTWARD ON THE COUTERTOP WITHIN AN INCH FROM THE UNIT, BUT WAS NOT TOUCHING IT AND RECEIVED A SHOCK. IT WAS REPORTED THAT DURING THE INCIDENT NONE OF THE OTHER MONITORS WENT OUT -- THE TELEMETRY WAS STILL WORKING AND NO TROUBLE WAS SEEN WITH THE UNIT. IT WAS REPORTED THAT THE VISION CENTRAL STATION WAS PLUGGED INTO A SURGE PROTECTOR AND THEN PLUGGED INTO A UPS (UNINTERRUPTIBLE POWER SUPPLY). IT WAS REPORTED THAT AT THE TIME OF THE INCIDENT, THE WEATHER OUTSIDE WAS STORMY, BUT IT WAS UNK IF THERE WERE ELECTRICAL STORMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION CENTRAL STATION PT MONITOR DRT INVIVO CORPORATION 20500-16H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other