BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 2844934 · Received October 24, 2012

    Report

    Report Number
    1722139-2012-01078
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MMOG MED DEVICES GROUP
    Product Code
    LZH
    PMA / PMN Number
    K031199
    Removal / Correction Number
    TBD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT THE DIODE D7 WAS DETERMINED TO BE LEAKY AND WAS CUT OF THE SPECIFICATION. NEW PCB WAS REPLACED TO SOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT PUMP WAS PART OF IDENTIFIED POPULATION AT RISK AND FAILED THE DIODE TEST DURING TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1