BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOCARE INFINITY 2 PUMP, WE

    MDR report key: 2251606 · Received August 30, 2011

    Report

    Report Number
    1722139-2011-00281
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 17, 2010
    Report Date
    August 20, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    STANDARD FUNCTIONAL TESTS WERE PERFORMED, COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. THIS MDR IS BEING FILED AS PART OF THE RETROSPECTIVE REVIEW FOR REPORTABILITY.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE PUMP CONTINUED TO RUN AFTER THE SET WAS EMPTY AND DID NOT SHOW AIR ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOCARE INFINITY 2 PUMP, WE LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability