BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3083165 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10689
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CUSTOMER REPORTED PROBLEM OF F-38 WAS CONFIRMED DURING ON-SITE EVALUATION. THE FORCE SENSING RESISTOR(FSRS)WERE FOUND TO BE DAMAGED AND WERE REPLACED TO RESOLVE THE ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING THE INITIAL EVALUATION. THE DEVICE IS CURRENTLY BEING EVALUATED ON-SITE. UPON COMPLETION OF THE EVALUATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP ALARMED FAILURE CODE 38 DURING POWER-UP. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION RELATED TO THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185427 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1