BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ PUMP MEDNET WIRELESS

    MDR report key: 1230808 · Received November 6, 2008

    Report

    Report Number
    2921482-2008-00354
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    June 2, 2008
    Report Date
    October 13, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY THE HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPT WITH A NOTE INDICATING AN ALARM CONDITION AND "NO AUDIBLE ALARMING". NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION WHILE ON THE LOW OR HIGH VOLUME SETTINGS. THERE WERE NO REPORTS OF ANY ADVERSE PT EFFECTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE: LIST#20791