BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2961523 · Received January 17, 2013

    Report

    Report Number
    1722139-2013-00104
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WAS TESTED FOR ACCURACY USING WATER. PUMP DELIVERED AMOUNT WITHIN SPEC (+/- 5%). ALL ALARMS HAVE BEEN CHECKED AND WORKED PROPERLY. COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT PUMP IS NOT FEEDING. CUSTOMER WAS NOT ABLE TO PROVIDE ANY ADD'L INFO WHEN ASKED ABOUT WHAT WAS STOPPING THE FEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27000 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINTY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1