BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIVANTAGE DH

    MDR report key: 15657600 · Received October 24, 2022

    Report

    Report Number
    1518293-2022-00011
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 27, 2022
    Report Date
    September 27, 2022
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY- A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR 844001 SERIAL NUMBER (B)(4) ALLEGING A MECHANICAL FAILURE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL CLARIFICATION ON THE FAILURE WAS REQUESTED AND THE CUSTOMER REPORTED THAT THE INJECTOR WAS EXPERIENCING PROBLEMS WITH THE STABILITY IN THE MAIN ARM STATING ALLEGING THAT IT WAS UNABLE TO HOLD THE EQUIPMENT AT THE REQUIRED ANGLE. REGIONAL SERVICE WENT ON SITE TO INVESTIGATE THE REPORT THAT THE POWER HEAD, LOCATED ON A REMOTE PEDESTAL (STAND), WAS NOT ABLE TO HOLD THIS TILT (ANGLE) POSITION. IT WAS ALSO REPORTED THAT AN OPERATOR WAS IMPACTED BY A SUDDEN TURN OF THE PH ASSEMBLY AND A SECOND ISSUE WHERE THE OPERATOR WAS HIT IN THE HEAD BY THE POWER HEAD INSTALLED ON THE STAND. IN BOTH CASES, THERE WAS NO MAJOR INJURY, AND THE OPERATORS ARE WELL. THE SERVICE ENGINEER TROUBLESHOT AND FOUND THAT A USER HAD DISASSEMBLED THE PIVOT/BRAKE SYSTEM PARTS FROM THE POWER HEAD AND REINSTALLED THEM IN AN INCORRECT MANNER. THE RESULT WAS THAT THE POWER HEAD COULD NOT BE TIGHTENED ON THE PIVOT ENOUGH TO KEEP THE POWERHEAD IN THE DESIRED POSITION DURING THE SYSTEM'S USAGE. SERVICE MANUAL 848083 SHOWS A DIAGRAM IN FIGURE 6-3-8, AS DOES MANUAL 848586 FIGURE 3-3-1, OF THE CORRECT ASSEMBLY FOR THE POWER HEAD PIVOT/BRAKE SYSTEM. SERVICE ENGINEER CORRECTED THE ASSEMBLY, RESOLVING THE ISSUE, AND THE EQUIPMENT WAS RELEASED UNDER NORMAL OPERATION. THE OPERATOR WAS INSTRUCTED ABOUT THE RISKS ON HANDLING THE RELATED PIVOT BUSHING SYSTEM. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY- REPORTED THAT AN OPERATOR WAS IMPACTED BY A SUDDEN TURN OF THE PH ASSEMBLY AND ALSO WHERE AN OPERATOR WAS HIT IN THE HEAD BY THE POWER HEAD. NO MAJOR INJURY WAS SUSTAINED. THE UNIT HAS BEEN RELEASED FOR USE. ROOT / PROBABLE CAUSE CODE- PERSONNEL - PERFORMANCE - FAILED TO FOLLOW PROCEDURE ROOT / PROBABLE CAUSE SUMMARY- REFER TO INVESTIGATION SUMMARY. NO ADDITIONAL CAPA REQUIRED AT THIS TIME. GUERBET QUALITY WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEW AND DURING THE MANAGEMENT REVIEWS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY- UNIT RETURNED TO CUSTOMER USE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN CALAMA, CHILE ON (B)(6) 2022. THE REPORTER STATES THAT THEY EXPERIENCED MECHANICAL FAILURE OF THE OPTIVANTAGE SYSTEM, ALSO STATING THAT THERE WAS NO PATIENT INVOLVEMENT. THE REPORTER CLARIFIED THAT THE INJECTOR WAS EXPERIENCING PROBLEMS WITH THE STABILITY IN THE MAIN ARM STATING ALLEGING THAT IT WAS UNABLE TO HOLD THE EQUIPMENT AT THE REQUIRED ANGLE. IT WAS ALSO REPORTED THAT AN OPERATOR WAS IMPACTED BY A SUDDEN TURN OF THE PH ASSEMBLY AND A SECOND ISSUE WHERE THE OPERATOR WAS HIT IN THE HEAD BY THE POWER HEAD INSTALLED ON THE STAND. IN BOTH CASES, THERE WAS NO MAJOR INJURY, AND THE OPERATORS ARE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821505 OPTIVANTAGE DH OPTIVANTAGE DH IZQ LIEBEL-FLARSHEIM 844001 C1113B512X

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown