BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 103140 · Received July 2, 1997

    Report

    Report Number
    103140
    Event Type
    Malfunction
    Date Received
    July 2, 1997
    Date of Event
    June 5, 1997
    Report Date
    June 16, 1997
    Manufacturer
    SMV AMERICA
    Product Code
    JWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 6/5/97, WHILE GATED STRESS SCANS WERE BEING OBTAINED, THE CAMERA CAME INTO CONTACT WITH PT. TECH IMMEDIATELY ATTEMPTED TO REDACT CAMERA HEAD. CAMERA DID NOT REDACT ON COMMAND BUT INSTEAD MOVED CLOSER TO PT. REDACT COMMAND WAS GIVEN AGAIN TO THE CAMERA HEAD WENT IN THE OPPOSITE DIRECTION AGAIN WHICH RESULTED IN PINNING PT TO TABLE. EMERGENCY FUNCTIONS WERE UTILIZED AND PROCEDURE DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FX-40 W/VISION POWERSTATION & ASPECT IMAGES JWM SMV AMERICA FX-40 #151 3BT

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other