BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2791932 · Received October 15, 2012

    Report

    Report Number
    1416980-2012-02486
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. THE CAUSE WAS DETERMINED TO BE A DAMAGED POWER CORD. TO CORRECT THE CONDITION, THE POWER CORD WAS REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THIS DEVICE WAS SERVICED FOR PREVENTATIVE MAINTENANCE. DURING INITIAL INSPECTION, A BAXTER TECHNICIAN FOUND BROKEN POWER CORD. THIS WAS NOT REPORTED BY THE CUSTOMER AND THE CUSTOMER DID NOT ALLEGE ANY PRODUCT MALFUNCTION OR DEFECT. THERE WAS NO PATIENT INVOLVED; THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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