BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ 3 MEDNET SW

    MDR report key: 3960367 · Received June 23, 2014

    Report

    Report Number
    9615050-2014-04132
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    FA210-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, CHANNEL 3 OF THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CTR FOR RECERTIFICATION. DURING VERIFICATION TESTING AT THE SERVICE CTR, CHANNEL 3 OF THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THIS ERROR OCCURS WHEN THE BATTERY CANNOT BE FULLY CHARGED WITHIN EIGHT HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366259 PLUM A+ 3 MEDNET SW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA