BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3944554 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23269
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 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. A VISUAL INSPECTION, ALARM LOG REVIEW AND POWER ON SELF-TEST WERE PERFORMED. DURING THE ALARM LOG REVIEW AND POWER-ON SELF-TEST AN F38 ALARM WAS IDENTIFIED. THIS ALARM INDICATES THAT THE FORCE SENSING RESISTOR'S (FSR'S) ARE OUT OF SPECIFICATION. THE FSR'S WERE REPLACED TO RESOLVE THE ISSUE. THE PUMP PASSED ALL SUBSEQUENT 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-38 ALARM (MALFUNCTION IN TUBE MISLOADING DETECTION CIRCUITRY). THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423690 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1