BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 1744345 · Received June 29, 2010

    Report

    Report Number
    1722139-2010-00073
    Event Type
    Injury
    Date Received
    June 29, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 28, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER PROVIDED NOTIFICATION ONLY. THE PUMP WAS RETURNED TO PEDIATRIC HEALTH CHOICE. SHOULD MORE INFO BECOME AVAILABLE A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: PUMP CONTINUED TO PUMP AIR INTO THE PT AFTER FOOD WAS GONE. INCIDENT OCCURRED TWICE. THE CAREGIVER REPORTS THAT SHE MAY HAVE TO TAKE HER SON TO THE HOSPITAL AS A RESULT.

    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