BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2993701 · Received March 7, 2013

    Report

    Report Number
    1416980-2013-05560
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED, DURING ON SITE EVALUATION, AS DAMAGED FORCE SENSING RESISTORS (FSR). THE CAUSE OF THE DAMAGED FSRS COULD NOT BE DETERMINED. SERVICE REPLACED THE FSRS TO CORRECT THE PROBLEM.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLOGARD INFUSION PUMP THAT "WAS NOT WORKING." IT IS UNKNOWN WHEN THIS EVENT OCCURRED, HOWEVER THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT/USER INJURY NOR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97370 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1