BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4031502 · Received August 22, 2014

    Report

    Report Number
    1416980-2014-27732
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 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 AS PART OF PREVENTIVE MAINTENANCE. THIS IS AN ANCILLARY SERVICE EVENT. THE DEVICE WAS VISUALLY INSPECTED, POWER ON SELF-TESTED AND THE ALARM LOG AND SERVICE HISTORY LOG WERE REVIEWED. DURING POWER ON SELF-TEST AND ALARM LOG REVIEW THE F-38 ALARM WAS FOUND; THE CAUSE OF THIS WAS DAMAGED FORCE SENSING RESISTORS (FSR). TO CORRECT THE CONDITION, THE FSRS WERE REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING PRODUCT SERVICE BY A FIELD SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE AN F-38 ALARM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509208 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1