BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 9670563 · Received February 5, 2020

    Report

    Report Number
    3010293992-2020-00004
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 4, 2020
    Report Date
    April 26, 2020
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G.1 DISTRIBUTOR INFORMATION: ICU MEDICAL, INC. US SERVICE CENTER (B)(4). EXEMPTION NUMBER, E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL.

    Description of Event or Problem · 0

    THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE- PRIMING ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4) EXEMPTION NUMBER, E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM (B)(6)- PRIMING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134241 N/A INFUSION PUMP FRN Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1