BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2061039 · Received April 4, 2011

    Report

    Report Number
    1722139-2011-00053
    Event Type
    Other
    Date Received
    April 4, 2011
    Report Date
    April 2, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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). THE SET THAT WAS USED WITH THIS PUMP WHEN THE MALFUNCTION OCCURRED COULD HAVE CONTRIBUTED TO THIS MALFUNCTION BUT WAS NOT RETURNED FOR EVALUATION. CONCLUSION: THE ALLEGED COMPLAINT/DEFECT COULD NOT BE DUPLICATED. THE PUMP PERFORMED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED; PUMP NOT ALARMING WHEN DOSE IS DONE. NO FURTHER INFORMATION PROVIDED. INJURY OR MEDICAL INTERVENTION REPORTED? NO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK