BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3842292 · Received June 1, 2014

    Report

    Report Number
    1416980-2014-17577
    Event Type
    Malfunction
    Date Received
    June 1, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THE EVENT HISTORY LOG REVIEW SHOWED EVIDENCE OF A BROKEN DOOR ALARM. THE VISUAL INSPECTION VERIFIED THE DAMAGED DOOR, THOUGH THE CAUSE OF THIS DAMAGE WAS UNABLE TO BE DETERMINED. A POWER-ON SELF TEST WAS ALSO PERFORMED. TO CORRECT THE CONDITION, THE DOOR ASSEMBLY WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A BROKEN DOOR ALARM ON THE FLOGARD INFUSION PUMP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320653 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1