BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULM A+ PUMP

    MDR report key: 1061818 · Received June 13, 2008

    Report

    Report Number
    2921482-2008-00188
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 4, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED "SPARKS WHEN PLUGGED IN". THE PUMP WAS RETURNED TO THE MATERIALS MGMT DEPT WITH AN UNSIGNED NOTE THAT STATED, "SPARKS WHEN PLUGGED IN". NO TRACKING INFO WAS PROVIDED;THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULM A+ PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK