BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY IGS 740

    MDR report key: 7628439 · Received June 22, 2018

    Report

    Report Number
    9611343-2018-00004
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    May 25, 2018
    Report Date
    October 3, 2018
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K113403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ON MAY 25, 2018 DURING A SERVICE ACTIVITY, GE HEALTHCARE FIELD SERVICE ENGINEER OBSERVED A FLEXING MOVEMENT OF THE LARGE DISPLAY MONITOR (LDM) SUSPENSION WHEN IT REACHED THE END STOP POSITION. THE SUSPENSION DID NOT FALL AND THERE WAS NO REPORT OF PATIENT IMPACT. NEVERTHELESS, THIS FLEXING ISSUE COULD POTENTIALLY LEAD TO A FALL OF THE ENTIRE SUSPENSION. GE HEALTHCARE ENGINEERING INVESTIGATION OF THIS EVENT WAS PERFORMED USING INFORMATION PROVIDED BY GE HEALTHCARE FIELD SERVICE ENGINEER AND FROM SYSTEM PRE-INSTALLATION MANUAL. GE HEALTHCARE FIELD SERVICE ENGINEER CONFIRMED THAT THE INSTRUCTIONS FOR THE INSTALLATION OF THE SUB-STRUCTURE OF THE DUAL ARM SUSPENSION WERE NOT PROPERLY FOLLOWED. IT HAS BEEN CONFIRMED THAT THIS IS A SITE SPECIFIC ISSUE AND ISOLATED CASE. GE HEALTHCARE PRE-INSTALLATION MANUAL PROVIDES ALL NECESSARY INFORMATION FOR A PROPER INSTALLATION. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE WAS THE NON-OBSERVANCE OF THE INSTALLATION INSTRUCTIONS BY GE HEALTHCARE CONTRACTOR THAT HAS INSTALLED THE SUB-STRUCTURE WHICH CONNECTS THE SUSPENSION TO THE CEILING. ON AUGUST 3, 2018, THE TOTAL SUB-STRUCTURE AND THE DUAL ARM SUSPENSION WAS COMPLETELY RE-INSTALLED FOLLOWING INSTALLATION INSTRUCTIONS AND IN PRESENCE OF GE HEALTHCARE REPRESENTATIVES. SYSTEM IS NOW COMPLETELY FIXED. DURING THIS CORRECTION, GE HEALTHCARE CONTRACTOR HAS ALSO BEEN REMINDED ON THE PROPER WAY TO INSTALL THIS SUSPENSION. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NO PATIENT HAS BEEN INVOLVED IN THIS ISSUE. UDI NUMBER WILL BE PROVIDED IN THE FINAL REPORT. 510K WILL BE PROVIDED IN THE FINAL REPORT. DATE OF MANUFACTURING WILL BE PROVIDED IN THE FINAL REPORT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. THE DUAL ARM SUSPENSION AND ITS SUBSTRUCTURE ARE DESIGNED AND MANUFACTURED BY (B)(6) (B)(4) (ORIGINAL EQUIPMENT MANUFACTURER) BUT THE SUSPENSION IS PART OF THE GE HEALTHCARE VASCULAR SYSTEM. IN THIS CASE, THE SUBSTRUCTURE HAS BEEN INSTALLED BY A THIRD PARTY COMPANY. A FIRST ROOT CAUSE ANALYSIS SHOWED THAT THIS ISSUE MAY BE DUE TO AN IMPROPER INSTALLATION OF THE SUB-STRUCTURE PERFORMED BY THE THIRD PARTY COMPANY. A DEEPER ANALYSIS OF THIS ISSUE IS STILL IN PROGRESS, AND FURTHER INFORMATION WILL BE PROVIDED AS PART OF THE FINAL REPORT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    ON (B)(6) 2018 DURING A SERVICE ACTIVITY, GE HEALTHCARE FIELD SERVICE ENGINEER OBSERVED A FLEXING MOVEMENT OF THE LARGE DISPLAY MONITOR (LDM) SUSPENSION WHEN IT REACHED THE END STOP POSITION. THE SUSPENSION DID NOT FALL AND THERE WAS NO REPORT OF PATIENT IMPACT. NEVERTHELESS, THIS FLEXING ISSUE COULD POTENTIALLY LEAD TO A FALL OF THE ENTIRE SUSPENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474000 DISCOVERY IGS 740 DISCOVERY IGS 740 OWB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1