BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTX AFM

    MDR report key: 1611662 · Received February 18, 2010

    Report

    Report Number
    9611343-2010-00006
    Event Type
    Injury
    Date Received
    February 18, 2010
    Date of Event
    January 27, 2010
    Report Date
    February 18, 2010
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    PMA / PMN Number
    K905653
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE INVESTIGATED THE REPORTED ISSUE, AND DETERMINED THE ROOT CAUSE TO BE INCORRECT SERVICING OF THE EQUIPMENT BY THE HOSP. EACH MONITOR IS FIXED ON A SEPARATE MONITOR YOKE, AND EACH MONITOR YOKE IS ASSEMBLED WITH A SCREW, WASHER AND A NUT ON THE SUSPENSION CROSS BAR ARM. FIELD ENGINEER (FE) CONFIRMED THAT ON THIS MONITOR ASSEMBLY, NO WASHER WAS PRESENT. THE NUT WAS COMPLETELY UNSCREWED, AND UNDER THE WEIGHT OF THE PT, THE NUT CAME OFF AND CAUSED THE ENTIRE MONITOR AND ITS YOKE TO COME OFF OF THE SUSPENSION ARM. THE FE CONFIRMED THAT THE SECOND MONITOR ASSEMBLY WAS CORRECTLY INSTALLED WITH A WASHER AND NUT. FURTHER INVESTIGATION INTO THE ISSUE REVEALED THAT THE HOSP HAD SENT THE MONITOR ASSEMBLY TO A THIRD PARTY FOR REPAIR BETWEEN SIX AND TWELVE MONTHS PRIOR TO THE EVENT. THE CUSTOMER DID NOT RE-INSTALL THE MONITOR CORRECTLY ON THE SUSPENSION ARM. NO REQUEST WAS MADE TO GE SERVICE TO ASSIST WITH RE-INSTALLATION OF THE MONITOR. THE MONITOR IS NOW PROPERLY INSTALLED AT THE CUSTOMER SITE. THE FE HAS CHANGED THE SCREWS, WASHERS AND NUTS ON BOTH MONITORS AND HAS INSPECTED THE ENTIRE MONITOR SUSPENSION PER SERVICE DOCUMENTATION REQUIREMENTS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A SEDATED PT GRABBED THE REF MONITOR OF THE ADVANTX AFM SYSTEM, ATTEMPTING TO PULL HIMSELF UP. A NURSE TRIED TO STOP THE PT, BUT WAS UNABLE TO REACH HIM IN TIME. THE FIXING NUT OF THIS MONITOR CAME LOOSE FROM THE PT'S WEIGHT AND FELL ON THE RIGHT SIDE OF HIS FACE, BREAKING THE PT'S CHEEKBONE (AS REVEALED BY A CT SCAN) AND CAUSING MINOR SCRATCHES TO THE NURSE'S HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTX AFM VASCULAR X-RAY SYSTEM IZI GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other