BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 1823787 · Received August 27, 2010

    Report

    Report Number
    1722139-2010-00081
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 26, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE WAS EVALUATED. RESULTS: THE EVALUATION INCLUDED PERFORMANCE TESTING (ACCURACY, VERIFICATION OF AIR/NO FOOD ALARM, ETC). MULTIPLE FORMULAS AND SETTINGS WERE USED TO RECREATE THE FAILURE EXPERIENCED BY THE CUSTOMER. THE PUMP PERFORMED ACCORDING TO SPECIFICATION DURING EACH RUN (ALARMED AND SHUT OFF AFTER FOOD WAS GONE). CONCLUSION: THE ALLEGED COMPLAINT/DEFECT COULD NOT BE DUPLICATED. THE PUMP PERFORMED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    PUMP DID NOT ALARM OR SHUT DOWN AFTER FOOD WAS GONE DELIVERING AIR TO THE PATIENT. NO PATIENT INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1