BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D670 TANDEM

    MDR report key: 5006638 · Received August 13, 2015

    Report

    Report Number
    9613299-2015-00008
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 3, 2015
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K093514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED NO DEFECT WAS IDENTIFIED IN THE TABLE DESIGN, SYSTEM INVOLVED OR ITS ASSOCIATED SERVICE INSTRUCTIONS. THE FIELD ENGINEER (FE) DID NOT INSTALL PROTECTION MODULES TO STOP THE TABLE FROM FALLING DOWN PRIOR TO WORK INITIATION, AS IS REQUIRED PER THE SERVICE MANUAL. THE INVESTIGATION CONCLUDES THE INCIDENT OCCURRED DUE TO THE FE NOT FOLLOWING THE INSTRUCTIONS.

    Description of Event or Problem · 1

    DURING REPAIR, THE BACK OF THE FIELD ENGINEER'S (FE) HEAD WAS HIT AGAINST THE PT TABLE WHICH WENT DOWN SUDDENLY, DUE TO THE FE FAILING TO INSTALL PROTECTION MODULES TO STOP THE TABLE FALLING DOWN AS THE MANUAL REQUESTS. HIS FACE CAME IN CONTACT WITH THE CONTROL BOX EDGE CAUSING A WOUND REQUIRING 10 STITCHES ON HIS FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532266 D670 TANDEM SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other