BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRA GENISYS 2CH COMBO PKG

    MDR report key: 1995977 · Received February 14, 2011

    Report

    Report Number
    MW5019435
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 14, 2011
    Manufacturer
    CHATTANOOGA GROUP INC
    Product Code
    IMG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERFORMING ULTRASOUND TO PT'S RIGHT LATERAL EPICONDYLE. AT 9 MINUTES AND 28 SECONDS, THE PT EXPERIENCED A SHOCK FROM THE PROBE THAT MADE HER JUMP OUT OF HER CHAIR. THIS WAS THE SECOND PT OF THE DAY TO HAVE ULTRASOUND WITH THIS MACHINE, THE FIRST WAS STILL PRESENT AND STATED THAT SHE HAD BEEN FEELING LITTLE SHOCKS AND THOUGHT THAT WAS NORMAL. DURING (B)(6) , 2 PTS EXPERIENCED SHOCKS FROM THIS MACHINE. THE MACHINE WAS SENT TO THE MFR FOR REPAIR AND A PROBE WAS REPORTEDLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS 2CH COMBO PKG VECTRA GENISYS 2CH COMBO PKG IMG CHATTANOOGA GROUP INC 2761 NO NUMBER

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR