BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2890614 · Received November 21, 2012

    Report

    Report Number
    1722139-0120-01185
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS NOT RETURNED. ATTEMPTS WERE MADE TO OBTAIN PUMP SERIAL NUMBER AND PATIENT INVOLVEMENT WITH NO RESPONSE. THEREFORE, A DHR COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM NURSECOMM CALL STATES THAT PUMP ALARMS ERROR CODE 13.

    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 OSMOLITE 1.6