BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ PUMP MEDNET WIRELESS

    MDR report key: 1031457 · Received April 18, 2008

    Report

    Report Number
    2921482-2008-00128
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 30, 2008
    Report Date
    March 30, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THIS WAS DUE TO THE AUDIO BUZZER. THE DEVICE NOT AUDIBLY ALARMING DURING AN ALARM CONDITION THAT IS BEING REPORTED BEING WAS NOTED DURING VERIFICATION TESTING; THEREFORE, USER FACILITY EVENT CODES ARE NOT APPLICABLE IN THIS CASE.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION.

    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