BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAR ELITE NPS

    MDR report key: 12300242 · Received August 10, 2021

    Report

    Report Number
    1518293-2021-00016
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 12, 2021
    Report Date
    July 12, 2021
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K073592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2021. THE CUSTOMER REPORTED THAT PRIOR TO THE INJECTION, THE OPERATOR PRESSED THE "P" ON THE POWERHEAD TO CHECK FOR PATENCY. REPORTER IS INDICATING THAT ONCE HE PRESSED THE PATENCY, THE INJECTOR INJECTED BOTH THE CONTRAST AND SALINE, AND DID NOT TRY TO STOP IT. THE REPORTER HAD THE INJECTOR PROGRAMMED FOR 2ML/SEC, A SIDE 20ML AND SIDE B 35ML SALINE. REPORTER STATS THAT PATIENT WAS CONNECTED AT THE TIME, NOT INJURED BUT THEY HAD TO RESCHEDULE THE EXAM. SINCE THIS OCCURRED, CUSTOMER HAS USED THE INJECTOR BUT NOT USING THE PATENCY FUNCTION. REPORTER ALSO STATES THAT THERE WAS NO RESULTS SCREEN ON THE INJECTOR AFTER THIS HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202555 OPTISTAR ELITE NPS OPTISTAR ELITE NPS DXT LIEBEL-FLARSHEIM 814004 C0421D896G

    Patients

    Seq Age Sex Outcome Treatment
    1