BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HCLL 2014 R2 CS

    MDR report key: 11701707 · Received April 21, 2021

    Report

    Report Number
    3006129391-2019-00002
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    January 30, 2019
    Report Date
    February 18, 2019
    Manufacturer
    WELLSKY CORPORATION
    Product Code
    MMH
    PMA / PMN Number
    BK160066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED, THAT WITHIN THE CUSTOMER PRODUCTION ENVIRONMENT, HCLL 2014 R2 CS APPEARED TO SCAN A UNIT AS O+. DURING SUBSEQUENT PRODUCT MODIFICATION PROCESSES, THE APPLICATION DISPLAYED THE UNIT AS O-. AS A RESULT, THERE IS POTENTIAL THAT THE SCANNED UNIT MAY DOCUMENT A DIFFERENT BLOOD TYPE. CURRENTLY THIS EVENT IS NOT ABLE TO BE REPRODUCED AND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596274 HCLL 2014 R2 CS HCLL 2014 R2 CS MMH WELLSKY CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other