BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3782113 · Received April 30, 2014

    Report

    Report Number
    1416980-2014-13988
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    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 BATTER LOW ALARM WAS CONFIRMED IN THE ALARM LOG. A POWER-ON SELF-TEST WAS PERFORMED. THE ROOT CAUSE OF REPORTED BATTER LOW ALARM WAS DETERMINED TO BE A DEFECTIVE BATTERY. TO CORRECT THE CONDITION, THE BATTERY WAS REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. 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 RECEIVED A BATTERY LOW ALARM. NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION WAS REPORTED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260253 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1