BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV WEB SERVER HL

    MDR report key: 2201198 · Received July 29, 2011

    Report

    Report Number
    1225058-2011-00003
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    April 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LMB
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO PERTINENT TO EVAL (CONCLUSION): THE DEVICE IN QUESTION DID NOT FAIL. THE SITE WAS IN THE PROCESS OF MIGRATING DATA TO NEW SERVERS. AS A RESULT OF THE MIGRATION, THE MEDICAL DEVICE OPERATING REQUIREMENTS WERE COMPROMISED WHEN THE SITE RE-ROUTED THE NETWORK CONNECTION. THE SITE'S HARDWARE DID NOT INCLUDE ENOUGH PORTS TO MEET IMPAX CV REQUIREMENTS DURING THE MIGRATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(6), USA REPORTED BEING UNABLE TO ACCESS IMAGES IN THE OPERATING ROOM VIA THE CARDIO WEB SERVER. THE SYSTEM RESUMED FUNCTIONING WITHOUT INTERVENTION FROM THE SITE OR (B)(4). IT IS ESTIMATED THAT THE INCIDENT MAY HAVE AFFECTED CV WEB USERS FOR APPROX 30-60 MINUTES. THERE WERE TWO SURGICAL PROCEDURES IN PROGRESS DURING THE INTERRUPTION. THE SITE HAS NOT PROVIDED ANY EXPLICIT DETAILS DESCRIBING THE SURGERIES BUT NO ADVERSE CLINICAL EVENT WAS REPORTED AS A RESULT OF THE INTERRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX CV WEB SERVER HL DIGITAL IMAGE STORAGE - RADIOLOGICAL LMB AGFA HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1