BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMARAD DIGITAL RADIOGRAPHY SYSTEM

    MDR report key: 1950154 · Received December 9, 2010

    Report

    Report Number
    3006335802-2010-00002
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    September 8, 2010
    Report Date
    February 11, 2010
    Manufacturer
    IMIX AMERICAS, INC.
    Product Code
    KPR
    PMA / PMN Number
    K073114
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IMIX IS REPORTING THIS INCIDENT AS MANUFACTURER AND SYSTEM INTEGRATOR OF SONORAD DIGITAL RADIOGRAPHY SYSTEM WHICH INTEGRATES IMIX DIGITAL RADIOGRAPHY DETECTOR WITH THE STAND MANUFACTURED BY (B)(4). BASED ON THE PRELIMINARY INVESTIGATION, INITIALLY, IT WAS CONSIDERED AS AN ISOLATED INCIDENT AND AN ERROR BY THE OPERATOR AND THE INVESTIGATIONS DID NOT REVEAL ANY ROOT CAUSE FOR THE PROBLEM. AFTER FURTHER STUDIES AND ENGINEERING EVALUATION OF THE UNIT, IT WAS DETERMINED THAT AN INTERFERENCE INTRODUCED BY THE ELECTRICAL NOISE FROM THE EXTERNAL KEY PAD CONTROL UNIT COULD RESULT IN SUCH A MOVEMENT. ALL OTHER POSSIBLE SCENARIOS WERE RULED OUT. AS A CORRECTIVE ACTION, A FIELD NOTICE WAS ISSUED TO DISCONNECT THE EXTERNAL KEY PAD CONTROL UNIT. THIS DOES NOT HAVE AN EFFECT ON FUNCTIONALITY OR SAFETY OF THE DEVICE. AS A PREVENTIVE ACTION, IMIX IS PLANNING TO INSTALL A COLLISION SENSOR AS AN ADDED SAFETY FEATURE TO AVOID ANY SUCH UNINTENDED MOVEMENT. IMIX'S INTERNAL CORRECTIVE ACTION (B)(4) WILL CONTINUE UNTIL EFFECTIVENESS OF THE CORRECTIVE/ PREVENTIVE ACTION IS CONFIRMED. THIS REPORT IS NOT MEETING THE FDA'S REQUIRED REPORTING TIME FRAME DUE TO THE FACT THE IMIX DID NOT IDENTIFY THIS INCIDENT AS A REPORTABLE EVENT. HOWEVER, AFTER CAREFUL STUDY OF THE EVENT/S, IMIX MANAGEMENT DECIDED TO SEND THIS REPORT TO FDA.

    Description of Event or Problem · 1

    SOMARAD DIGITAL X-RAY RADIOGRAPHY SYSTEM WAS IN USE AT THE (B)(6). THE STAND BEGAN TO MOVE BY ITSELF AND THE OPERATOR ACTIVATED THE EMERGENCY OFF SWITCH TO STOP THE MOVEMENT. THERE WAS A PT IN THE VICINITY BUT THE MOVEMENT DID NOT IMPACT THE PT. NO INJURY TO A PT. NO ACCIDENTAL RADIATION EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOMARAD DIGITAL RADIOGRAPHY SYSTEM DIGITAL X-RAY IMAGING SYSTEM KPR IMIX AMERICAS, INC. SOMARAD

    Patients

    Seq Age Sex Outcome Treatment
    1 NO PATIENT INVOLVED