BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2873614 · Received November 14, 2012

    Report

    Report Number
    1722139-2012-01162
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO OBTAIN PUMP SERIAL NUMBER. CUSTOMER HAS ALREADY HAD PUMP REPLACED. SERIAL NUMBER WAS NOT AVAILABLE. DEVICE WAS NOT RETURNED. COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM (B)(6) CALL STATES THAT PUMP ALARMS ERROR CODE 13. RATE IS 60 ML/HR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR OSMOLITE 1.6