BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4821835 · Received June 5, 2015

    Report

    Report Number
    1416980-2015-24274
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 13, 2015
    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. THE DEVICE WAS VISUALLY INSPECTED, FUNCTIONALLY TESTED AND AN ALARM LOG REVIEW WAS PERFORMED. THE F-49 ALARM WAS IDENTIFIED DURING FUNCTIONAL TESTING AND ALARM LOG REVIEW. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DUE TO A BATTERY THAT WOULD NOT RETAIN CHARGE. THE DEVICE WAS REMOVED FROM SERVICE. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD INFUSION PUMP HAD AN F49 ALARM CODE. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365202 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1