BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY IGS 740

    MDR report key: 6085511 · Received November 8, 2016

    Report

    Report Number
    9611343-2016-00015
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 8, 2016
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K113403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 IT WAS REPORTED THAT A GE HEALTHCARE FIELD SERVICE ENGINEER EMPLOYEE HAD HIS HAND CRUSHED DURING TABLE MOTOR DRIVE ASSEMBLY REPLACEMENT IN CUSTOMER SITE. THE SERVICE MANUAL REQUIRES THE USE OF THE LOTO (LOCK OUT TAG OUT) TOOL TO PREVENT THE TABLE FROM FALLING DURING THE MOTOR REPLACEMENT BUT THE INVESTIGATION SHOWED THAT GE HEALTHCARE FIELD SERVICE ENGINEER DID NOT FOLLOW THE APPROPRIATE MANUAL INSTRUCTIONS, EVEN IF THE ONE FOLLOWED BY GE HEALTHCARE FIELD SERVICE ENGINEER REQUIRES ALSO TO USE THE SAME LOTO TOOL. GE HEALTHCARE FIELD SERVICE ENGINEER COMPLETED ALL REQUIRED TRAININGS FOR DISCOVERY IGS 740 SYSTEM AND WAS QUALIFIED TO LEAD A DISCOVERY IGS 740 SYSTEM INSTALLATION. BUT THE INNOVA IQ TABLE TRAINING WAS NOT A PREREQUISITE. ON DECEMBER 12, 2016 TRAINING DATABASE WAS UPDATED TO HAVE THIS TRAINING A PREREQUISITE. ON JANUARY 2, 2017 ALL USA GE HEALTHCARE FIELD SERVICE ENGINEERS COMPLETED THIS TRAINING. ON THIS SPECIFIC SITE, CUSTOMER DID NOT ALLOW LOTO TOOL KIT TO BE ON SITE DUE TO INFECTIOUS CONTROL STANDARDS. THE LOTO TOOL KIT NOT BEING ON THE SITE WAS NOT A CONTRIBUTING FACTOR. THE LOTO TOOL KIT IS NOW STORED IN THE CONTROL ROOM AT THIS SITE. A NEW TABLE WAS INSTALLED AT CUSTOMER SITE. BASED ON THIS ANALYSIS, NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SYSTEM MAINTENANCE IN CUSTOMER SITE, THE GE HEALTHCARE (GEHC) FIELD ENGINEER (FE) HAD HIS LEFT HAND CAUGHT AND PINCHED UNDERNEATH A TABLE TOP FOR AN HOUR. HE WAS TAKEN TO THE EMERGENCY DEPARTMENT WHERE X-RAYS WERE PERFORMED. IT WAS DETERMINED THAT THERE WERE MULTIPLE FRACTURES AND MISALIGNMENT TO 2ND, 3RD, 4TH AND 5TH DIGITS. HE WAS ADMITTED TO THE HOSPITAL AND HAD OPEN REDUCTION, MULTIPLE SCREWS PLACED AND AMPUTATION OF LEFT 4TH DIGIT (RING FINGER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737083 DISCOVERY IGS 740 INTERVENTIONAL FLUOROSCOPIC X-RAY SY OWB GE MEDICAL SYSTEMS SCS XCA461, XCA461, XCA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability