BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3895082 · Received June 25, 2014

    Report

    Report Number
    1416980-2014-20301
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. THE DEVICE WAS POWER ON SELF-TESTED AND THE ALARM LOG WAS REVIEWED. DURING VISUAL INSPECTION DAMAGE WAS NOTED TO THE DOOR AND LATCH ROLLER. THE CAUSE OF THE DAMAGE WAS DUE TO NATURAL WEAR AND TEAR. TO CORRECT THE CONDITION, BOTH THE DOOR AND LATCH ROLLER WERE REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING PRODUCT SERVICE BY A SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE A DAMAGED DOOR LATCH AND A DAMAGED DOOR ROLLER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371786 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1