BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 3181757 · Received June 6, 2013

    Report

    Report Number
    1722139-2013-01851
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    Z-0294-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT THE DIODE D7 WAS DETERMINED TO BE LEAKY AND WAS OUT OF THE SPEC. NEW PCB BOARD WAS REPLACED TO SOLVE THE ISSUE. REFERENCE RECALL # Z-0294-2013.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT PUMP ALARMS ERROR CODE 13 DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252055 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1