BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERBANK ENTERPRISE EDITION 1.0

    MDR report key: 1202919 · Received October 17, 2008

    Report

    Report Number
    3006611234-2008-00001
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    ECLIPSYS INDIA PVT. LTD.
    Product Code
    MMH
    PMA / PMN Number
    BK060014
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BACKGROUND: WHEN RECEIVED INTO POWERBANK ENTERPRISE (B) (4), SOME UNITS ARE FLAGGED AS UNCHECKED SO THAT BLOOD GROUP AND OTHER CRITERIA MAY BE VERIFIED BEFORE MAKING THE UNITS AVAILABLE FOR ASSIGNMENT. THERE ARE TWO WAYS TO CHANGE THE UNCHECKED UNITS TO AVAILABLE UNITS: MANUAL - FROM THE UNIT DETAILS WINDOW, THE OPERATOR ACCEPTS THE UNCHECKED UNIT, MAKING IT AVAILABLE; AUTOMATIC - A BACKGROUND PROCESS RUNS AT FIXED INTERVALS TO CHECK ALL UNCHECKED UNITS. RESULTS ARE THEN COMPARED WITH PREVIOUS RESULTS. IF RESULTS ARE UN-POSTED OR DON'T MATCH PREVIOUS RESULTS, THE UNIT IS NOT MADE AVAILABLE. IF ALL CRITERIA ARE MET, THE SYSTEM MAKES THE UNIT AVAILABLE. INVESTIGATION SUMMARY: A USER REPORTED THAT A UNIT WAS FLAGGED AVAILABLE, BUT RESULTS WERE NOT POSTED. THE DEVICE IS SOFTWARE AND CANNOT BE PHYSICALLY RETURNED. WE USED OUR COPY OF THE SOFTWARE FOR TESTING. WE WERE UNABLE TO RECREATE THE INCIDENT AND FOUND NO EVIDENCE OF SOFTWARE ERROR. HOWEVER, WE HAVE ADDED AN UPGRADE TO ENHANCE CONTROL. WE HAVE ADDED AN ADD'L LAYER OF CODE THAT WILL PERFORM A SECOND CHECK THAT RESULTS ARE ON FILE AND MEET CRITERIA PRIOR TO CHANGING THE STATUS TO AVAILABLE. THIS CHECK WILL OVERRIDE THE AVAILABILITY OF THE SELECTED UNIT IF THE RESULTS DO NOT MEET CRITERIA OR IF THE RESULTS FILE IS UNAVAILABLE. THIS CHANGE WILL BE MADE AVAILABLE TO ALL CURRENT USERS AND HAS BEEN INCORPORATED INTO ALL NEW DISTRIBUTIONS OF THE SOFTWARE.

    Description of Event or Problem · 1

    REPORTED INCIDENT: A USER REPORTED THAT THE STATUS OF A BLOOD UNIT, WHOSE BLOOD GROUP WAS REQUIRED TO BE CONFIRMED BEFORE BEING RESERVED TO A PATIENT, WAS ENTERED AS UNCHECKED. THE STATUS OF THIS UNIT SUBSEQUENTLY APPEARED AS AVAILABLE FOR RESERVATION, EVEN THOUGH THE BLOOD GROUP CHECK RESULT WAS NOT POSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERBANK ENTERPRISE EDITION 1.0 MMH ECLIPSYS INDIA PVT. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1