BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATROL PUMP

    MDR report key: 1430528 · Received April 22, 2009

    Report

    Report Number
    1527460-2009-00039
    Event Type
    Malfunction
    Date Received
    April 22, 2009
    Date of Event
    February 1, 2009
    Report Date
    March 10, 2009
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K943733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LZH PUMP, INFUSION, ENTERAL. THE TESTING AND INVESTIGATION RESULTS INDICATE THE COMPLAINT OF UNDER DELIVERY WAS CONFIRMED, DUE TO A STUTTERING MOTOR.

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE INTENDED RATE WAS 150ML/HR; HOWEVER, THE PUMP DELIVERED 45ML IN 30 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL PUMP FOR ENTERAL PUMPS LZH ABBOTT NUTRITION 52036

    Patients

    Seq Age Sex Outcome Treatment
    1