BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2000

    MDR report key: 7296400 · Received February 26, 2018

    Report

    Report Number
    9611343-2018-00001
    Event Type
    Injury
    Date Received
    February 26, 2018
    Date of Event
    January 30, 2018
    Report Date
    March 26, 2018
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K022322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE INVESTIGATION ABOUT THIS EVENT HAS BEEN COMPLETED. ON JANUARY 30, 2018 IT WAS REPORTED THAT DURING MAINTENANCE ACTIVITY ON AN INNOVA 2000 VASCULAR SYSTEM, A GE HEALTHCARE FIELD SERVICE ENGINEER HAD TO REMOVE TABLE COVERS. WHEN REASSEMBLING THE COVERS, HE COULD NOT HOLD THE MOBILE COVER PROPERLY IN THE CONSTRAINED ENVIRONMENT, AND THE COVER SLIPPED FROM HIS HAND. THE FALLING COVER CAME IN CONTACT WITH THE SOFT SKIN OF HIS LEFT HAND PALM BETWEEN THUMB AND INDEX FINGER AND HURT HIS PALM. HE RECEIVED ANTIBIOTICS AND TETANUS SHOT. STITCHES WERE REQUIRED AS WELL AS A RIGID SPLINT FOR THE INJURY HE GOT. GE HEALTHCARE FIELD SERVICE ENGINEER CONFIRMED THAT HE WAS WEARING PROTECTION GLOVES DURING THIS INTERVENTION. IT WAS ALSO CONFIRMED THAT THERE WAS NO SHARP CUTTING EDGES, BURRS OR DAMAGES WITH THE TABLE COVERS. ADEQUATE INSTRUCTIONS ARE PROVIDED IN INSTALLATION MANUAL REGARDING PROPER REMOVAL AND ASSEMBLY OF TABLE COVERS. NEITHER DESIGN, ASSEMBLY NOR MANUFACTURE DEFECT, NOR FAILURE OR MALFUNCTION HAS BEEN IDENTIFIED WITH THE TABLE COVER. THIS IS AN ISOLATED CASE. THIS EVENT IS DUE TO AN IMPROPER HOLDING OF THE COVER BY GE HEALTHCARE FIELD SERVICE ENGINEER. GE HEALTHCARE FIELD SERVICE ENGINEER WAS CONTACTED AND FOUND TO BE AWARE OF TABLE MOBILE COVER FIXING PROCEDURE AND ABOUT THE APPROPRIATE PPE (PERSONNEL PROTECTIVE EQUIPMENT) USAGE. NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING TROUBLESHOOTING AN ISSUE ON THE VASCULAR TABLE, GE HEALTHCARE FIELD SERVICE ENGINEER SUSTAINED A LACERATION TO HIS THUMB (OF HIS DOMINANT HAND) WHILE HANDLING A TABLE COVER. GE HEALTHCARE FIELD SERVICE ENGINEER WAS CONDUCTING A REPAIR AND REMOVING THE COVERS WHEN ONE OF THE COVERS FELL AND CUT HIS LEFT THUMB. GE HEALTHCARE FIELD SERVICE ENGINEER RECEIVED ANTIBIOTICS AND TETANUS SHOT. STITCHES WERE REQUIRED AS WELL AS A RIGID SPLINT FOR THE INJURY HE GOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139683 INNOVA 2000 INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention