BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4031511 · Received August 22, 2014

    Report

    Report Number
    1416980-2014-27731
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 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 FLOGARD INFUSION PUMP WAS SERVICED ON-SITE. A VISUAL INSPECTION, ALARM LOG REVIEW, POWER ON SELF-TEST AND AN INTERNAL BATTERY TEST WERE PERFORMED. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. HOWEVER, DURING THE POWER UP SELF-TEST AND THE ALARM LOG REVIEW AN F-38 ALARM WAS IDENTIFIED. THIS ALARM WAS CAUSED BY DAMAGED FORCE SENSING RESISTORS (FSR'S). THE FSR'S WERE REPLACED TO FIX THE MALFUNCTION. THE PUMP PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER IN GOOD WORKING ORDER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP EXPERIENCED AN F-35 ALARM (FRONT PANEL KEY WAS PRESSED FOR MORE THAN 40 SECONDS). THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509211 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1