BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROPHY ELITYS INTRAORAL

    MDR report key: 331512 · Received May 4, 2001

    Report

    Report Number
    MW1021821
    Event Type
    Malfunction
    Date Received
    May 4, 2001
    Manufacturer
    TREXTROPHY DENTAL DIVISION
    Product Code
    EHD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THIS WILL REPORT ON A VERY DANGEROUS X-RAY MACHINE THAT THE REPORTER PURCHASED IN 1996. TROPHY ELITYS INTRAORAL X-RAY INSTALLED 15 NOV 1996. THE RVG PORTION OF THE SYSTEM WAS PURCHASED ON 27 OCT 1997. ALL WERE PURCHASED THROUGH HILL DENTAL SUPPLY (NOW PATTERSON DENTAL SUPPLY) TROPHY RADIOLOGY, INC, MFR (NOW TREX DENTAL DIVISION OF TREX MEDICAL CORP; DANBURY CT). THE RCG PORTION OF THE SYSTEM NEVER WORKED CORRECTLY AND REPEATED CALLS WERE MADE TO TROPHY. PROMISES OF SERVICE WERE MADE AND NOT FOLLOWED UP. WITHIN THE FIRST YEAR, THE BRACKET HOLDING THE ARM BROKE IN HALF ALLOWING THE ARM AND HEAD (WEIGHT 11.2KG) TO DROP. THIS HAS HAPPENED THREE TIMES. FORTUNATELY, THE MACHINE WAS NOT BEING USED WHEN IT BROKE. REPORTER IS SO AFRAID THAT IT WILL BREAK AGAIN AND DROP THE HEAD ON A PT OR SELF THAT REPORTER ONLY USES IT WHEN THE OTHER MACHINE IS IN USE. ALSO THE GAS JACKS THE KEEP THE ARM IN POSITION ARE DESIGNED FOR 400,000 CYCLES, BUT IT FAILED IN LESS THEN TEN PERCENT OF THAT. FOR SOME REASON, BOTH TROPHY AND TREX HAVE COMPLETELY IGNORED REPORTER'S PROBLEMS WITH THIS MACHINE. THE LAST REPAIR COSRT REPORTER $500 TO FIX. REPORTER CAN'T BELIEVE REPORTER HAS THE ONLY MACHINE THAT HAS HAD A PROBLEM. REPORTER FINDS THE WHOLE SITUATION UNBELIEVABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20602 TROPHY ELITYS INTRAORAL X-RAY UNIT EHD TREXTROPHY DENTAL DIVISION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 *