BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NPR BBK MODULE

    MDR report key: 66376 · Received February 4, 1997

    Report

    Report Number
    MW1010658
    Event Type
    Malfunction
    Date Received
    February 4, 1997
    Date of Event
    May 1, 1995
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    USERS WERE UNABLE TO SUCCESSFULLY FIB A POOLED UNIT DUE TO A SOFTWARE MALFUNCTION. THIS COULD LEAD TO INAPPROPRIATE LABELLING OF BLOOD PRODUCTS. RESOLVED WITH PROGRAMMING CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NPR BBK MODULE SOFTWARE INFORMATION SYSTEM LNX BOSTON SCIENTIFIC CORP. V4.3,V4.4,V4.5,V4.6 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *