BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUCLEAR IMAGING DIAGNOSTIC CAMERA

    MDR report key: 105838 · Received July 14, 1997

    Report

    Report Number
    1527587-1997-00002
    Event Type
    Other
    Date Received
    July 14, 1997
    Date of Event
    July 7, 1997
    Report Date
    July 11, 1997
    Manufacturer
    TRIONIX RESEARCH LAB., INC.
    Product Code
    JWM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    PROBABILITY OF REOCCURANCE IS LOW FREQUENCY OF EVENT 1 TIME IN 10 YEAR PERIOD, HAVING A SYSTEM WITH ALL THE SYMPTOMS OF THIS SITE IS VERY SLIM. THROUGH CO'S INTERNAL AND ON SITE INVESTIGATIONS, CO HAS DETERMINED THAT THE ROOT CAUSE HAD ADD'L CONTRIBUTING FACTORS. THE FOLLOWING IS A TIME LINE DEFINITION OF THE INCIDENT. - 1992 SYSTEM WAS MFG TO AN INADEQUATE ASSEMBLY PROCEDURE, IN THAT IT DID NOT SPECIFICALLY STATE TO LOCTITE THE BALL SCREW NUT BLOCK ASSEMBLY, THUS IT WAS AT THE MECHANICS DISCRETION AT THAT TIME TO USE LOCTITE OR NOT. - MARCH 18, AFTER 5 YEARS OF OPERATION THE BALL SCREW NUT BECAME UNSEATED FROM THE BALL SCREW NUT BLOCK, AS DID THE SET SCREW. CO'S FIELD SERVICE ENGINEER, DISCOVERED THE LOOSE ASSEMBLY DURING A PM, HE WAS INSTRUCTED ON HOW TO REPAIR IT OVER THE PHONE. - JULY 7, 1997 - WHILE MAPPING A PT THE ASSEMBLY LOOSENED A SECOND TIME, BECOMING UNCOUPLED FROM THE NUT BLOCK CAUSING THE DETECTOR HEAD TO FALL DOWNWARD TOWARD THE PT, CAUSING AN INJURY. - ONCE INFORMED TRIONIX SENT A TEAM TO THE SITE TO DETERMINE WHAT CAUSED THE FAILURE AND WHAT NEEDED TO BE DONE TO CORRECTLY FIX IT. INITIAL REPORTS STATED THAT THE SET SCREW HAD BECOME UNSEATED. - CO'S INITIAL REPORT ONLY SITED THE SET SCREW AS THE ROOT CAUSE, HOWEVER UPON THE RETURN OF THE MECHANIC WITH A FULL REPORT, AND THE INITIATION OF A FAILURE MODE AND EFFECT ANALYSIS, THE FOLLOWING WERE ALSO DETERMINED TO BE CONTRIBUTING FACTORS IN THE FAILURE: A. THE BALL SCREW ASSEMBLY WAS NOT LOCTITED TO THE NUT BLOCK DURING INITIAL ASSEMBLY & MFR. - THE ASSEMBLY PROCEDURE DID NOT DIRECT THE ASSEMBLER TO APPLY LOCTITE TO THIS AREA. - THE BLUE PRINT STATED TO LOCTITE ALL HARDWARE, THUS LEAVING ROOM FOR MISINTERPRETATION. B. THE FIELD SERVICE ENGINEER PERFORMING THE INITIAL REPAIR, DID NOT REALIZE THAT THE BALL SCREW WAS NOT PROPERLY SEATED. - THERE WAS DEBRIS LEFT OVER ON THE SHAFT OF THE SCREW AND IN THE NUT BLOCK, CAUSING THE BALL SCREW TO STOP PREMATURELY, GIVING HIM THE IMPRESSION IT WAS ALL THE WAY ON. - WHEN HE ENCOUNTERED RESISTANCE HE ASSUMED THAT IT WAS SEATED AS FAR AS IT WOULD GO. AFTER HIS REPAIR THE SYSTEM WAS UNSTABLE AND TOOK ONLY THREE MONTHS TO FAIL. AT THIS TIME CO IS CONTINUING WITH CO'S INTERNAL INVESTIGATION PROCESS ALONG WITH A METHOD OF PREVENTING REOCCURRENCE OF A SIMILAR FAILURE.

    Description of Event or Problem · 1

    ADD'L INFO GATHERED DURING INDEPTH INHOUSE, FAILURE MODE AND EFFECT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEAR IMAGING DIAGNOSTIC CAMERA GAMMA CAMERA JWM TRIONIX RESEARCH LAB., INC. TRIAD CLASSIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other