BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ ITALIAN DEVIC

    MDR report key: 3822829 · Received February 7, 2014

    Report

    Report Number
    9615050-2014-01016
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 10, 2014
    Manufacturer
    HOSIRA COSTA RICA LTD
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    FA210-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING. AN E321 (BATT CHARGER TIMEOUT) ERROR CODE WAS NOTED IN THE DEVICE HISTORY BUT WAS NOT DUPLICATED DURING TESTING. ALTHOUGH THE DEVICE PASSED TESTING, 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 CUSTOMER CONTACT REPORTED THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A REPORT OF "BATTERY CHARGER TIMEOUT." NO TRACKING INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PATIENT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPY WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80987 PLM A+ ITALIAN DEVIC 80FRN FRN HOSIRA COSTA RICA LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, LIST #12097 SN (B)(4)