BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEB1000 ENTERPRISE FULL BASE RADIOLOGY V5.0

    MDR report key: 2379049 · Received December 13, 2011

    Report

    Report Number
    2249582-2011-00005
    Event Type
    Death
    Date Received
    December 13, 2011
    Date of Event
    October 1, 2011
    Report Date
    December 13, 2011
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K053458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIPTION OF EVENT: THE DATE AFGA BECAME AWARE OF THIS ISSUE WAS (B)(6) 2011. A PATIENT DIED UNEXPECTEDLY IN (B)(6) 2011 IN (B)(6). THE CORONER HAS NOT DETERMINED CAUSE OF DEATH AT THIS TIME. AGFA WAS NOT NOTIFIED AT THE TIME OF THE PATIENT'S DEMISE. THE ATTENDING PHYSICIAN HAS STATED THAT THE INCORRECT IMAGE WAS USED FOR TREATMENT DUE TO (B)(4) STUDY LIST BEING IN THE US DATE/TIME FORMAT. EVALUATION: THE DEVICE HAS BEEN INSTALLED SINCE 2003 AT THE SITE AND THIS IS THE FIRST TIME AGFA HAS ENCOUNTERED MISUSE OF THE PRODUCT IN THIS MANNER AT ANY LOCATION. THE EPR LINK IS NOT A PRIMARY METHOD OF VIEWING/DIAGNOSING IMAGES AND ALL PHYSICIANS HAVE BEEN MADE AWARE OF THIS. THE ATTENDING PHYSICIAN USED THE DEVICE OFF-LABEL FOR DIAGNOSIS AND THE USER ERROR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE DATE AGFA BECAME AWARE OF THIS ISSUE WAS (B)(6) 2011. A PATIENT DIED UNEXPECTEDLY IN (B)(6) 2011 IN (B)(6). THE CORONER HAS NOT DETERMINED CAUSE OF DEATH AT THIS TIME. AGFA WAS NOT NOTIFIED AT THE TIME OF THE PATIENT DEMISE. THE ATTENDING PHYSICIAN HAS STATED THAT AN INCORRECT IMAGE WAS USED FOR TREATMENT DUE TO (B)(4) STUDY LIST BEING IN US DATE/TIME FORMAT VS THE (B)(6). THE DEVICE HAS BEEN INSTALLED SINCE 2003 AT THE SITE AND THIS IS THE FIRST TIME AGFA HAS ENCOUNTERED MISUSE OF THE PRODUCT IN THIS MANNER AT ANY LOCATION. THE EPR LINK IS NOT A PRIMARY METHOD OF VIEWING/DIAGNOSING IMAGES AND ALL PHYSICIANS HAVE BEEN MADE AWARE OF THIS. VIEWING OF IMAGES IN THE (B)(4) WILL SHOW (B)(6) DATE/TIME FORMAT. THE ATTENDING PHYSICIAN USED THE DEVICE OFF-LABEL FOR DIAGNOSIS AND THE USER ERROR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEB1000 ENTERPRISE FULL BASE RADIOLOGY V5.0 SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ AGFA HEALTHCARE CORP. 5.1.1. SU3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death