BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3252141 · Received July 29, 2013

    Report

    Report Number
    1416980-2013-20019
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 22, 2013
    Report Date
    July 4, 2013
    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 AT THE CUSTOMER SITE BY A FIELD SERVICE TECHNICIAN. FUNCTIONAL TESTING REVEALED THAT THE MALFUNCTION WAS AN F_94 ALARM AT POWER UP. THE CAUSE OF THIS MALFUNCTION WAS A DEPLETED MAIN BATTERY DUE TO A MISSING POWER CORD, WHICH WOULD NOT HAVE ALLOWED THE MAIN BATTERIES FROM BEING CHARGED. IN ORDER TO ADDRESS THIS CONDITION THE MAIN BATTERY AND POWER CORD WERE REPLACED. THE DEVICE WAS RESTORED TO GOOD WORKING CONDITION AND RETURNED TO THE CUSTOMER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP WAS NOT FUNCTIONING. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353077 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1