BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3071581 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-10039
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    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 INFORMATION: DEVICE EVALUATION: THE CUSTOMER REPORTED CONDITION OF A BROKEN DOOR LATCH WAS CONFIRMED DURING DEVICE EVALUATION. THE DOOR LATCH ASSEMBLY WAS REPLACED TO RESOLVE THE REPORTED CONDITION. IF ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT HAD A BROKEN DOOR LATCH. IT IS UNKNOWN IN WHICH CARE AREA OR PROCESS STEP THAT THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION RELATED TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172953 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1