BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+3 PUMP MEDNET WIRELESS

    MDR report key: 1193465 · Received October 7, 2008

    Report

    Report Number
    2921482-2008-00316
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    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 IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, CHANNEL 3 DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS 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+3 PUMP MEDNET WIRELESS 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA