BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3210352 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17701
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    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 AT THE CUSTOMER SITE AND THE SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED CONDITION OF CANNOT TURN ON WAS CONFIRMED AS A DAMAGED SENSOR PRINTED CIRCUIT BOARD (PCBA) ASSEMBLY. THE ROOT CAUSE OF THE REPORTED CONDITION WAS DUE TO THE DAMAGED SENSOR PCBA. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP WAS UNABLE TO TURN ON. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309644 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1