BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX 6.3.1 SU 16

    MDR report key: 2021340 · Received February 7, 2011

    Report

    Report Number
    2249582-2011-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 8, 2011
    Report Date
    February 7, 2011
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K022292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ISSUES HAVE BEEN IDENTIFIED AS THE POTENTIAL ROOT CAUSE TO THE INCIDENT AND AGFA HEALTHCARE IS ACTIVELY INVESTIGATING EACH ONE. EVAL SUMMARY: ON (B)(6) 2011, AN EMAIL ESCALATION WAS RECEIVED FROM THE (B)(6) MED CTR INDICATING THAT A PROBLEM HAD OCCURRED WITH THE IMPAX 6.3.1 SU 16 (PACS SERVER). DIAGNOSTIC IMAGES TAKEN OF A CHILD WERE DELAYED. OVERALL, A DELAY TIME BETWEEN 45-60 MINUTES FROM THE TIME SOME OF THE FILMS WERE TAKEN TO THE TIME THE PICU TEAM WAS ABLE TO VIEW THE RESULTS. ACCORDING TO (B)(6) (MED CTR) - THIS DELAY DID NOT IMPACT THE PT'S ULTIMATE OUTCOME (THE CHILD EXPIRED) AND DID NOT CAUSE A DELAY IN RECEIVING ANY SPECIFIC MEDICAL INTERVENTIONS. DETERMINATION OF CAUSE: THE DEVICE IN QUESTION (IMPAX 6.3.1 SU 16) WAS NOT THE CAUSE OF THE PRODUCT PROBLEM. AGFA HEALTHCARE IS CONTINUING TO INVESTIGATE THE INCIDENT TO DETERMINE THE ROOT CAUSE. THERE ARE SEVERAL CONTRIBUTING FACTORS THAT MAY RESULT IN IMAGES NOT ALWAYS BEING AVAILABLE IN A TIMELY FASHION FOR VIEWING ON THE IMPAX CLIENT. ALL OF THE FOLLOWING CONTINUE TO BE EXPLORED: DATA INTEGRITY ISSUES WITH DATA MIGRATED FROM LEGACY GE PACS. MIGRATION TECHNIQUES. HIGHLY CUSTOMIZED WORKFLOW TO PROVIDE "QC REQUIRED" OPERATION, AND CROSS CLUSTER OPERATION, BUT A PLAN IS BEING DEVELOPED TO RETURN TO A STANDARD CONFIGURATION. PROBLEMS WITH SOFTWARE/CONFIGURATION, PARTICULARLY WITH SCU AND SCP PROCESSES ON THE 3 WORK FLOW MANAGERS (WFM). POTENTIAL PROBLEMS WITH THE CITRIX NETSCALER LOAD BALANCER. POSSIBLE ARP POISONING. CORRECTIVE ACTION: AGFA HEALTHCARE WAS ABLE TO TEMPORALLY RESOLVE THE PROBLEM FOLLOWING DRIVER UPDATES AND MODIFICATIONS TO CONFIGURATION (DEACTIVATING WORK FLOW MANAGER 3). AGFA SUPPORT AND THE ONSITE CSE WILL CONTINUE TO MONITOR THE PERFORMANCE OF THE SYSTEM UNTIL THE INVESTIGATION AND CORRECTIVE ACTIONS ARE COMPLETE. THE DATE AGFA HEALTHCARE BECAME AWARE OF THE INCIDENT: (B)(4) 2011.

    Description of Event or Problem · 1

    FOUR PORTABLE CHEST IMAGES OF THE PT WERE PERFORMED. DURING EACH INSTANCE, A DELAY OF IMAGES ARRIVING TO THE AGFA PACS OCCURRED. THE CLINICAL CONSEQUENCE WAS A DELAYED DIAGNOSIS ON (B)(6) WHILE THE PT WAS IN RESPIRATORY DISTRESS. THERE WERE OTHER DELAYS ON (B)(6) DURING ROUTINE RADIOGRAPHIC MORNING ROUNDS. THE PT EXPIRED OVER THE WEEKEND; HOWEVER, ACCORDING TO (B)(6) MED CTR, THE DELAY DID NOT IMPACT THE PT'S ULTIMATE OUTCOME (THE CHILD EXPIRED), AND DID NOT CAUSE A DELAY IN RECEIVING ANY SPECIFIC MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPAX 6.3.1 SU 16 PACS LLZ AGFA HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR