BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, OPTIVANTAGE DH W/RFID

    MDR report key: 15730051 · Received November 4, 2022

    Report

    Report Number
    1518293-2022-00015
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 6, 2022
    Report Date
    October 6, 2022
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR 844003 SERIAL NUMBER (B)(4) ALLEGING THAT THE UNIT SWITCHED OFF SUDDENLY AND RESTARTED BY ITSELF ON ANOTHER OCCASION. THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ADVERSE EVENT AND NO HARM OR RISK TO THE PATIENT WAS REPORTED. THE COMPLAINT WAS DETERMINED TO BE A REPORTABLE EVENT ON THE BASIS THAT THE COMPLAINT CONDITION APPEARED TO BE AN UNCOMMANDED MOVEMENT. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT THE POWER HAD BEEN CYCLED, BUT NO MOVEMENT BY THE UNIT HAD BEEN NOTED. REGIONAL SERVICE VISITED THE SITE AND DETERMINED THERE WAS A SHORT CIRCUIT DUE TO CONTRAST SPILLS AND INGRESS INTO THE POWERHEAD. THE FIELD SERVICE ENGINEER (FSE) TROUBLESHOT THIS ISSUE BY REPLACING THE POWERHEAD PCBA 844375-1 THAT WAS DAMAGED FROM THE CONTRAST MEDIA INGRESS BY UTILIZING THE 844337S POWERHEAD DISPLAY UPGRADE KIT. AFTER REPAIR, THE FSE VERIFIED FULL FUNCTIONALITY OF THE SYSTEM UTILIZING THE OPTIVANTAGE SERVICE CHECKLIST 846130 AND RETURNED TO CUSTOMER USE. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM SHOWS NO RELATED ACTIVITY ON THIS UNIT. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY- NO INJURY TO THE PATIENT/USER REPORTED. ROOT / PROBABLE CAUSE CODE: EQUIPMENT/INSTRUMENT - FAILURE. 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 SERVICE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN MEXICO CITY, MEXICO ON 06 OCTOBER 2022. THE REPORTER STATES THAT THE OPTIVANTAGE INJECTOR 844003 SERIAL NUMBER (B)(4) UNIT SWITCHED OFF SUDDENLY AND RESTARTED BY ITSELF ON ANOTHER OCCASION. THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ADVERSE EVENT AND NO HARM OR RISK TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2798894 INJECTOR, OPTIVANTAGE DH W/RFID INJECTOR, OPTIVANTAGE DH W/RFID IZQ LIEBEL-FLARSHEIM 844003 C0116B568R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown