BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, OPTIVANTAGE DH W/RFID

    MDR report key: 2852410 · Received November 13, 2012

    Report

    Report Number
    1518293-2012-00208
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 13, 2012
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) COULD NOT DUPLICATE THE ISSUE. PROPER OPERATION OF THE INJECTOR WAS VERIFIED PER SERVICE CHECKLIST (B)(4). SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2012: CUSTOMER STATES VIA PHONE: SHE SET 2ML/SEC FOR A CT CHEST PROTOCOL FROM THE POWERHEAD. AS IT WAS INJECTING THE MALE (B)(6), PATIENT STATED FEELING THE CONTRAST. THE TECHNOLOGIST LOOKED AT THE PROTOCOL AND THE POWERHEAD READ 5ML/SEC. THE INJECTION WAS COMPLETED WITH A TOTAL VOLUME OF 75ML. UPON RETURNING TO THE CONTROL ROOM TO INITIATE THE SCAN, THE CONTROL ROOM CONSOLE READ 6.5ML/SEC. CUSTOMER STATES THEY DO NOT USE ANY PROTOCOLS OVER 4ML/SEC. THEY DID HAVE THE WEEKLY POWER TEST OF THE GENERATOR THAT MORNING. DURING THE POWER TESTING, THE INJECTOR WAS POWERED OFF. THIS WAS THE FIRST PATIENT OF THE DAY. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTOR, OPTIVANTAGE DH W/RFID IZQ LIEBEL-FLARSHEIM CO. OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR