BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2878309 · Received December 18, 2012

    Report

    Report Number
    1416980-2012-07629
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN, AND THE CONDITION WAS CONFIRMED. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS DETERMINED TO BE DEPLETED BATTERY. TO CORRECT THE CONDITION, THE BATTERY WAS REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2012 FIELD SERVICE TECHNICIAN (FSE) FM DURING A PREVENTIVE MAINTENANCE FROM IMSS HGZ 1 TEPIC; DETECTED THE EQUIPMENT FLO-GARD 6201 VOLUMETRIC INFUSION, SOFTWARE VERSION 1.14 PRESENT THE ALARM F.111 BATTERY LOW. NO PATIENT INJURY WAS REPORTED. SAMPLE WAS EVALUATED ON SITE BY THE FIELD SERVICE TECHNICIAN (FSE).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1