BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIGITAL DIAGNOST SINGLE DETECTOR

    MDR report key: 2593879 · Received May 24, 2012

    Report

    Report Number
    3003768251-2012-00014
    Event Type
    Other
    Date Received
    May 24, 2012
    Report Date
    April 26, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS DMC GMBH
    Product Code
    MQB
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IDENTIFIED THAT THE HOSPITAL WAS NOT AWARE ABOUT THE CORRECT SYSTEM WORKFLOW. AUTOMATIC STITCHING DOES NOT MEAN A SUCCESSFUL RATE OF 100 PERCENT. SUCCESSFUL AUTOMATIC STITCHING DEPENDS ON SEVERAL PREREQUISITES. IN FEW CASES, SOME MANUAL INTERVENTIONS MAY BE NECESSARY, E.Q. DUE TO INADEQUATE (RULER) COLLIMATION, PATIENT MOVEMENT / BREATHING. ACCORDING TO THE INSTRUCTION FOR USE, THE OPERATOR HAS TO CHECK THE COMPOSITE IMAGES FOR CORRECT STITCHING RESULTS. ADDITIONAL TRAINING DOCUMENTATION ACCORDING TO THIS ISSUE WILL BE GIVEN TO THE CUSTOMER VIA (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WAS NOT AWARE ABOUT HIS RESPONSIBILITY TO "MANUALLY" CHECK THE RESULTS OF AUTO STITCHED IMAGES. THIS WAS A GENERAL STATEMENT NOT AN EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL DIAGNOST SINGLE DETECTOR MQB, KPR MQB PHILIPS MEDICAL SYSTEMS DMC GMBH 712020

    Patients

    Seq Age Sex Outcome Treatment
    1