BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    MDR report key: 3173493 · Received June 12, 2013

    Report

    Report Number
    1722139-2013-01895
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    February 15, 2013
    Report Date
    May 17, 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
    IA, 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 SPECIFICATION. NEW PCB BOARD WAS REPLACED TO SOLVE THE ISSUE. REFERENCE RECALL NUMBER: Z-0294-2013.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT PUMP ALARMED ERROR CODE 13 WHEN TURNED ON. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266321 ENTERALITE INFINITY ENTERAL FEEDING PUMP LZH MOOG MEDICAL DEVICES GROUP INFINITY PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1