BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+3 MEDNET WRLSS

    MDR report key: 3770057 · Received January 28, 2014

    Report

    Report Number
    9615050-2014-00707
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 1, 2013
    Report Date
    November 27, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT CHANNELS 1 AND 2 OF THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH AN UNSIGNED NOTE STATING, "E321." 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 OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, CHANNELS 1 AND 2 OF THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60611 PLM A+3 MEDNET WRLSS 80 FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK