BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 6085397 · Received November 8, 2016

    Report

    Report Number
    1416980-2016-17027
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    September 20, 2016
    Report Date
    November 8, 2016
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. AN ALARM LOG REVIEW, FUNCTIONAL TESTING, VISUAL INSPECTION, AND SERVICE HISTORY REVIEW WERE PERFORMED. THE DEVICE CANNOT POWER ON ISSUE WAS NOT IDENTIFIED DURING DEVICE EVALUATION, HOWEVER A F-38 ALARM WAS DISCOVERED DURING THE ALARM LOG REVIEW AND FUNCTIONAL TESTING. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DAMAGED FORCE SENSING RESISTORS. THE DEVICE WAS REMOVED FROM SERVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD INFUSION PUMP COULD NOT POWER ON. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736421 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1