BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 2944108 · Received January 9, 2013

    Report

    Report Number
    1722139-2013-00031
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP SHOWED IMPACT BENT PLATEN CAUSING PLATEN WILL NOT CLOSE TO PERFORM TEST. PLATEN WAS REPLACED TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP SHOWED IMPACT BENT PLATEN CAUSING PLATEN WILL NOT CLOSE TO PERFORM TEST. PLATEN WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THAT BENDING PUMP'S PLATEN DOOR WILL NOT CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12987 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 4000 CMX

    Patients

    Seq Age Sex Outcome Treatment
    1