BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 1635587 · Received March 17, 2010

    Report

    Report Number
    1722139-2010-00029
    Event Type
    Injury
    Date Received
    March 17, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 16, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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.). PUMP PERFORMED ACCORDING TO SPECIFICATION. CONCLUSION: THE ALLEGED COMPLAINT/DEFECT COULD NOT BE DUPLICATED. IF MORE CUSTOMER/PT INFO BECOMES AVAILABLE, A F/U REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: "PUMP CONTINUED TO PUMP AFTER FOOD WAS GONE". PT INJURY: NO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1