BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL DIAGNOST

    MDR report key: 2417417 · Received January 10, 2012

    Report

    Report Number
    2417417
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 10, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHILIPS DIGITAL DIAGNOST AUTO-STITCHING ISSUES DATING BACK TO THE DATE OF INSTALL (SOFTWARE VERSION 2.1.2 AND WORKSPOT SOFTWARE VERSION 22.6.6):THE HOSPITAL PURCHASED AND INSTALLED 2 DIGITAL DIAGNOST (DR) X-RAY MACHINES FROM PHILIPS HEALTHCARE IN 2011. THEY ARE BOTH IN THE ORTHOPEDIC CLINIC AND AT THE TIME OF PURCHASE HAVE AUTO-STITCHING SOFTWARE PACKAGE WITH THE VERSION LISTED ABOVE.DURING THE CLINICAL APPLICATION TRAINING, AND MANY MORE TIMES UP TO THE DATE OF THIS REPORT, THE DEPARTMENT NOTICED 2 ISSUES. ON NUMEROUS OCCASIONS WE HAVE APPROACHED PHILIPS WITH THESE ISSUES ESPECIALLY THE AUTO-STITCHING PROBLEM:GHOSTING: DURING THE ACQUISITION OF IMAGES FOR SCOLIOSIS PATIENTS, TWO X-RAYS ARE TAKEN, ONE AFTER THE OTHER ON THE SAME BREATH HOLD. THE SYSTEM IS SUPPOSED TO TRANSFER THE FIRST IMAGE AND ERASE THE PLATE BEFORE THE SECOND IMAGE IS ACQUIRED. GHOSTING OCCURS WHEN RESIDUAL IMAGE DATA IS NOT COMPLETELY REMOVED FROM THE IMAGING PLATE BEFORE THE SECOND ONE IS ACQUIRED, LEAVING PART OF THE INITIALLY ACQUIRED INFORMATION ON THE SECOND IMAGE. THIS CAUSES ISSUES ESPECIALLY FOR THE RADIOLOGISTS AND CLINICIANS.AUTO-STITCHING: THE SOFTWARE IS SUPPOSED TO AUTOMATICALLY STITCH BOTH IMAGES TO FORM A SINGLE IMAGE. THE PROBLEM WITH THIS IS THAT OFTEN, THERE IS AN OVERLAP OF THE ACQUIRED IMAGES DURING THE STITCHING PROCESS LEADING TO DISTORTION OF THE FINAL IMAGE. THIS IMAGE, ESPECIALLY THE IMPROPER ALIGNMENT CREATED BY THE SOFTWARE CAUSES A SERIOUS PATIENT SAFETY ISSUE.WE HAVE CONTACTED PHILIPS ON THESE ISSUES AND THEY ARE AWARE OF THE SIGNIFICANT IMPACT THIS CAN CAUSE TO PATIENT SAFETY. THERE HAVE BEEN COMMUNICATIONS BETWEEN THE DEPARTMENT OF RADIOLOGY AND PHILIPS WITHOUT ANY SIGNIFICANT RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL DIAGNOST X-RAY SYSTEM, RADIOGRAPHIC, DR KPR PHILIPS MEDICAL SYSTEMS * *
    2 DIGITAL DIAGNOST X-RAY SYSTEM, RADIOGRAPHIC, DR KPR PHILIPS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *