BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 2980210 · Received February 1, 2013

    Report

    Report Number
    1722139-2013-00118
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 4, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP SHOWED IMPACT BENT PLATEN CAUSING PUMP FAILED 40 PSI TEST. PLATEN WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THAT PUMP'S PLATEN IS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45393 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 4000 CMS

    Patients

    Seq Age Sex Outcome Treatment
    1