BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 3963287 · Received June 19, 2014

    Report

    Report Number
    9615050-2014-04095
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    January 1, 2013
    Report Date
    January 22, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING, IT WAS NOTED THAT THERE WAS EVIDENCE OF ELECTRICAL SPARKING AND BURNING ON THE DRIVER PRINTED CIRCUIT BOARD. THIS WAS DUE TO A BROKEN COMPONENT ON THE DRIVER PRINTED CIRCUIT BOARD. THE CUSTOMER CONTACT'S REPORT OF E379 (L/S VALVE FAILURE) WAS DUPLICATED DURING TESTING. 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 WITH A REPORT FROM THE CUSTOMER CONTACT OF AN E379 (L/S VALVE FAILURE) ERROR CODE. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THERE WAS EVIDENCE OF ELECTRICAL SPARKING AND BURNING ON THE DRIVER PRINTED CIRCUIT BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359418 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA PLUM A+ SOFTWARE MODULE: LIST#20791, SN (B)(4)