BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EV650

    MDR report key: 11897721 · Received May 27, 2021

    Report

    Report Number
    1418964-2021-00001
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 5, 2021
    Manufacturer
    DEL MEDICAL
    Product Code
    IZZ
    UDI-DI
    00858340006011
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A SERVICE CALL, THE MANUFACTURE'S TECHNICAL SUPPORT REPRESENTATIVE WAS PROVIDING INSTRUCTIONS TO THE THIRD PARTY SERVICE ENGINEER TO SUPPORT DIAGNOSING A PERFORMANCE ISSUE. WHILE THE MANUFACTURERS TECHNICAL SUPPORT REPRESENTATIVE BELIEVED HE WAS CLEARLY COMMUNICATING THAT HE WAS PREVIEWING THE INSTRUCTIONS,THE THIRD -PARTY ENGINEER BEGAN TO PERFORM THE OPERATIONS BEFORE RECEIVING THE COMPLETE SAFETY PRECAUTIONS INSTRUCTIONS. THE MANUFACTURER'S REPRESENTATIVE WAS VERBALLY WALKING THE THIRD-PARTY ENGINEER THROUGH SECTION 5.4 OF THE EV650 SERVICE MANUAL. THIS SECTION CONTAINS A WARNING IMMEDIATELY PRECEDING THE STEP WHERE THE INCIDENT OCCURRED THAT READS "PROCEED WITH CAUTION. THE FOLLOWING STEPS CARRY RISK OF INJURY OR EQUIPMENT DAMAGE. WHEN YOU MAKE THE FOLLOWING CONNECTION THE TABLE WILL BEGIN TO MOVE IMMEDIATELY. THE TABLE WILL STOP ONLY WHEN YOU DISCONNECT THE OVERRIDE CABLE. THE LIMI SWITCHES WILL STOP THE TABLE. TO AVOID DAMAGES STOP THE TABLE AS SOON AS IT IS BACK WITHIN LIMITS RANGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792753 EV650 RADIOLOGICAL TABLE IZZ DEL MEDICAL EV650 00858340006011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention