BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ PUMP MEDNET WIRELESS

    MDR report key: 1052067 · Received May 21, 2008

    Report

    Report Number
    2921482-2008-00167
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 8, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT UPON INCOMING INSPECTION OF THE DEVICE PRIOR TO CLINICAL USE, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE