BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 2904334 · Received November 20, 2012

    Report

    Report Number
    1722139-2012-01179
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP SHOWED IMPACT BENT/DAMAGE PLATEN BUT PASSED 40 PSI AND ACCURACY TESTS AFTER ADJUSTMENTS TO THE PLATEN DOOR.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THAT PUMP'S PLATEN DOOR IS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 6000 PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1