BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ 3 MDNET SW

    MDR report key: 3832941 · Received March 26, 2014

    Report

    Report Number
    9615050-2014-02330
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 9, 2014
    Report Date
    February 10, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT CHANNELS 2 AND 3 OF THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THE DEVICE HAS BEEN IDENTIFIED IN 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 CENTER FOR A REPORT FROM THE CUSTOMER CONTACT THAT THERE WAS PHYSICAL DAMAGE ON THE OUTER CASING AND THE BATTERY NEEDS TO BE REPLACED. THESE ARE NOT REPORTABLE MALFUNCTIONS. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, CHANNEL 2 OF THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THIS ERROR CODE OCCURS WHEN THE BATTERY CANNOT BE FULLY CHARGED WITHIN 8 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176528 PLUM A+ 3 MDNET SW 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA