BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPAX CV 7.8SU3

    MDR report key: 3001330 · Received March 13, 2013

    Report

    Report Number
    1225058-2013-00188
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    AGFA HEALTHCARE CORP.
    Product Code
    LLZ
    PMA / PMN Number
    K050228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGFA INITIATED AND REPORTED A REPORTABLE CORRECTION TO THE FDA ON MARCH 15, 2013. INCLUDED IN THIS CORRECTION IS A REVIEW OF THE DESIGN CONTROL PROCESS WITH A TARGET DATE OF MAY 2013. AGFA'S RECALL NUMBER, (B)(4), HAS YET TO BE REVIEWED OR CLASSIFIED BY THE FDA. (B)(4).

    Description of Event or Problem · 1

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADVISE FDA OF RESULTS OF AGFA'S INVESTIGATION AND OUR REPORTING OF THE MEDICAL DEVICE; REPORT OF CORRECTION, TO THE FDA, FOR THE ISSUE DESCRIBED IN THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, OCR SERVICE WAS INSTALLED FOR USE AT (B)(6) HOSPITAL. (B)(6) 2013, THE CUSTOMER PACS ADMINISTRATOR, (B)(6), REPORTED TO AGFA THE NUMERIC WEIGHT VALUE WAS INSERTED INTO THE HEIGHT FIELD WITHIN THE PEDIATRIC ECHOCARDIOGRAPHY REPORT MODULE, AND THE WEIGHT FIELD WAS BLANK (NO NUMERIC VALUE). AGFA INVESTIGATION REVEALED A DESIGN ERROR IN THE SOFTWARE. IT WAS DISCOVERED TO BE AFFECTING THE SCREEN READING OF THE HEIGHT AND WEIGHT NUMERIC VALUES AND HOW THOSE VALUES APPEAR WITHIN THE PEDIATRIC ECHOCARDIOGRAPHY REPORTING MODULE. AGFA CONFIRMED THE VALUE FOR WEIGHT IS INSERTED INTO THE HEIGHT FIELD, WHILE THE WEIGHT FIELD IS THEN DISPLAYED AS BLANK. ALSO AFFECTED IS THE BODY SURFACE AREA (BSA) FIELD CALCULATION, WHICH IS BASED ON THESE INACCURATE WEIGHT AND HEIGHT FIELDS. FOR CORRECTIVE ACTION, AS AN INTERIM MEASURE, AGFA HAS INSTRUCTED THE CUSTOMER TO OBSERVE AGFA'S RECOMMENDATION TO DISREGARD ALL IMPORTED HEIGHT AND WEIGHT MEASUREMENTS FOR ALL PEDIATRIC ECHOCARDIOGRAPHY EXAMS AND MANUALLY ENTER THE CORRECT VALUES FOR THOSE 2 SPECIFIC MEASUREMENTS AND THEN RE-CALCULATE THE BODY SURFACE AREA (BSA) FOR VALUES. THIS CUSTOMER IS THE ONLY SITE USING IMPAX CV 7.8SU3, SPECIFICALLY OCR SERVICE FOR PEDIATRIC MEASUREMENT IMPORT. A SOFTWARE CHANGE IS UNDERWAY AND IS PLANNED FOR IMPLEMENTATION BY APRIL 30, 2013. NO REPORTS OF PATIENT HARM WERE REPORTED DURING THIS EVENT. DURING THE INVESTIGATION IT WAS DISCOVERED THREE (3) STUDY DATES WERE IMPACTED AND INCLUDED NINE (9) PATIENT ID NUMBERS. AGFA WILL SUBMIT A MDR TO THE FDA FOR EACH OF THE THREE (3) STUDY DATES AND INCLUDE THE SPECIFIC PATIENT ID NUMBERS REFERENCING EACH STUDY DATE. THE MDR SUBMISSION NAMES FOR THE ENTIRE EVENT WILL INCLUDE: 1225058-2013-00187 THROUGH 122058-2013-00189 THIS MDR INCLUDES: STUDY DATE: (B)(6) 2013 PATIENT ID NUMBERS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105213 IMPAX CV 7.8SU3 IMPAX CV 7.8SU3 -OCR SERVICE LLZ AGFA HEALTHCARE CORP. IMPAX CV 7.8 SU3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1