BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJ. OPTIV DH, W/OEM

    MDR report key: 9395307 · Received December 2, 2019

    Report

    Report Number
    1518293-2019-00024
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 4, 2019
    Report Date
    November 4, 2019
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OVERALL INVESTIGATION SUMMARY INCIDENT: (ISSUE 1) ALARM 2005 ALARM - (ISSUE 2) WAS ABLE TO TURN OFF FROM BACK OF POWER SUPPLY, BUT 'IT GAVE A SHOCK TO THE TECHNOLOGIST'. REGIONAL SERVICE COMPLETED REPAIR (ISSUE 1) BY INSTALLING NEW PH BOARD (LED BACKLIT DISPLAY POWERHEAD PCB ASS'Y, 844345-1). CONCERNING THE SHOCK THAT WAS RECEIVED BY THE OPERATOR (ISSUE 2) : SERVICE INSPECTED THE POWER SUPPLY BOX POWER CORD, AC POWER INLET MODULE AND THE AC WIRING HARNESS INSIDE THE BOX AND NO ISSUES WERE FOUND THAT COULD CAUSE A POTENTIAL SHOCK SITUATION. ALSO, WHEN SPEAKING TO THE OPERATOR, THEY ADMITTED THAT THE SHOCK THAT WAS RECEIVED COULD HAVE BEEN DUE TO STATIC ELECTRICITY AND NOT DUE TO AN EQUIPMENT FAILURE ISSUE OF THE INJECTOR. SERVICE COULD NOT DUPLICATE 'ISSUE 2'. SERVICE VERIFIED OPERATION ACCORDING TO OPTIVANTAGE TEST AND INSPECTION DATA CHECKLIST (846130). THE INJECTOR WAS FULLY FUNCTIONAL. OK TO USE. CTS HISTORY SEARCH SHOWS NO OTHER SIMILAR ISSUES WITH THIS UNIT. ROOT/PROBABLE CAUSE CODE. EQUIPMENT/INSTRUMENT - FAILURE. ROOT / PROBABLE CAUSE SUMMARY. SEE FAILURE MODE (SEE COMPONENTS AND OVERALL INVESTIGATION SUMMARY). CONCERNING ISSUE1 (ALARM 2005), SERVICE COMPLETED REPAIR BY INSTALLING NEW PH BOARD (LED BACKLIT DISPLAY POWERHEAD PCB ASS'Y, 844345-1). CONCERNING ISSUE 2, THE SHOCK THAT WAS RECEIVED BY THE OPERATOR (ISSUE 2), SERVICE INSPECTED THE POWER SUPPLY BOX POWER CORD, AC POWER INLET MODULE AND THE AC WIRING HARNESS INSIDE THE BOX AND NO ISSUES WERE FOUND THAT COULD CAUSE A POTENTIAL SHOCK SITUATION. ALSO, WHEN SPEAKING TO THE OPERATOR, THEY ADMITTED THAT THE SHOCK THAT WAS RECEIVED COULD HAVE BEEN DUE TO STATIC ELECTRICITY AND NOT DUE TO AN EQUIPMENT FAILURE ISSUE OF THE INJECTOR. SERVICE COULD NOT DUPLICATE 'ISSUE 2'. NO FURTHER INVESTIGATION NEEDED AT THIS TIME. QA WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. NO CAPA AT THIS TIME, THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEWS AND DURING THE MANAGEMENT REVIEW MEETINGS TO CONSIDER INPUT FOR CORRECTIVE ACTION. DISPOSITION SUMMARY: FOR ISSUE 1: SERVICE INSTALLED NEW PH BOARD (LED BACKLIT DISPLAY POWERHEAD PCB ASS'Y, 844345-1). FOR ISSUE 2: SERVICE COULD NOT DUPLICATE 'ISSUE 2'. AFTER REPAIR, SERVICE VERIFIED OPERATION. THE INJECTOR WAS FULLY FUNCTIONAL. OK TO USE.

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED ON 04 NOVEMBER 2019, AS REPORTER STATES THAT AN ALARM 2005 WAS PRESENTING ON THE OPTVANTAGE INJECTOR. THE TECHNOLOGIST WAS ABLE TO TURN OFF FROM BACK OF POWER SUPPLY BUT IT GAVE A SHOCK TO THE TECHNOLOGIST. THE REPORTER STATES THAT THIS EVENT DID NOT HAPPEN DURING A PROCEDURE, AND THAT THERE WAS NOT PATIENT ATTACHED TO THE DEVICE WHEN THE INCIDENT OCCURRED. THE REPORTER STATES THAT THERE WAS NO INJURY TO PATIENT OF STAFF THAT REQUIRED MEDICAL INTERVENTION, BUT STATES THAT OPERATOR DID RECEIVE A SHOCK WHEN CYCLING POWER FROM THE REAR OF THE POWER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193842 INJ. OPTIV DH, W/OEM INJ. OPTIV DH, W/OEM IZQ LIEBEL-FLARSHEIM 844007

    Patients

    Seq Age Sex Outcome Treatment
    1