BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATA INNOVATIONS INSTRUMENT MANAGER V.8.XX

    MDR report key: 16113031 · Received January 5, 2023

    Report

    Report Number
    MW5114195
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 3, 2023
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    MMH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE ARE USING MEDICAL BLOOD DEVICE BK180245. INSTRUMENT MANAGER V8. THIS MORNING AROUND 3AM MST THE INFORMATION TECHNOLOGY DEPARTMENT REBOOTED BOTH THE PRIMARY AND HIGH AVAILABILITY SERVERS AT THE SAME EXACT TIME WITHOUT PERFORMING THE PROPER SEQUENCE FOR REBOOT OF THIS FDA CLEARED BLOOD ESTABLISHMENT SOFTWARE. THEY DID NOT SHUT DOWN THE INSTRUMENT MANAGER SOFTWARE, NOR THE CACHE DATABASES ON EITHER SERVER, NOR FAILOVER THE DATABASE FROM THE PRIMARY TO THE HIGH AVAILABILITY SERVER AND PERFORM THE SOFTWARE UPDATES ONE SERVER AT A TIME TO ENSURE THE INTEGRITY OF THE FDA APPROVED BLOOD ESTABLISHMENT SOFTWARE TO MAINTAIN ITS VALIDATION. AT THIS TIME (LABORATORY SERVICES), WE ARE NOT EXPERIENCING ANY DATA CORRUPTION AS FAR AS WE CAN TELL BUT WE ARE NOT EXPERTS IN DATA CORRUPTION ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438967 DATA INNOVATIONS INSTRUMENT MANAGER V.8.XX BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES MMH DATA INNOVATIONS LLC V8 XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other