BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORNIER RELAX + TABLE

    MDR report key: 4917729 · Received July 14, 2015

    Report

    Report Number
    1037955-2015-00014
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    DORNIER MEDTECH SYSTEM GMBH
    Product Code
    LNS
    PMA / PMN Number
    P840008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE EVALUATION AND ANALYSIS OF THE SUSPECT RELAX-BAND HAND CONTROLLER COMPONENT, THE FOLLOWING CAN BE CONCLUDED: THE FAILURE OF THE HAND CONTROLLER WAS LIKELY NOT DUE TO ANY INHERENT DESIGN FLAW. THIS IS A VERY RARE OCCURRENCE WHOSE SPECIFIC CAUSE COULD NOT BE DETERMINED. THIS CUSTOMER IS NOT UNDER A DORNIER SERVICE CONTRACT. THEREFORE, DORNIER DOES NOT KNOW THE SERVICE CAPABILITIES OR QUALIFICATIONS OF THE 3RD PARTY THAT SERVICES THE DEVICE, NOR THE SERVICE/MAINTENANCE HISTORY OF THIS DEVICE. WE BELIEVE THE CAUSE COULD BE RELATED TO LACK OF PROPER INSPECTION AND MAINTENANCE AT APPROPRIATE FREQUENCY BY THE 3RD PARTY SERVICE CONTRACTOR. THERE IS NO TREND OF THIS FAILURE MODE IN THE FIELD ON ANY UNITS. (B)(4).

    Description of Event or Problem · 1

    THE RELAX+TABLE PAIRED WITH THE COMPACT DELTA LITHOTRIPTER (B)(4) STARTED GOING UP AND WOULDN'T STOP WHILE A PATIENT WAS ON THE TABLE. POSSIBLE PATIENT INJURY WAS REPORTED. THE PATIENT WAS SENT FOR AN X-RAY AND EXAMINED AT THE HOSPITAL THAT DAY AND SUBSEQUENTLY RELEASED. TWO WEEKS AFTER THE INCIDENT THE PATIENT WAS CONTACTED BY THE HOSPITAL AND REPORTED NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455978 DORNIER RELAX + TABLE RELAX+ TABLE LNS DORNIER MEDTECH SYSTEM GMBH K1018869

    Patients

    Seq Age Sex Outcome Treatment
    1 Other