BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSCAM

    MDR report key: 1624652 · Received March 5, 2010

    Report

    Report Number
    2916556-2010-00001
    Event Type
    Other
    Date Received
    March 5, 2010
    Report Date
    February 5, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    921296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NUCLEAR MEDICINE TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS THAT DETECTOR MOUNTING BOLTS LOOSENED OVER TIME DUE TO EXCESSIVE VIBRATION DURING IN-HOSPITAL TRANSPORTATION. THESE LOOSE BOLTS DID NOT MAINTAIN THE DETECTOR/DETECTOR ARM INTERFACE PROPERLY WHICH CAUSED EXCESSIVE STRAIN/WEAR TO THE BOLTS AND THEY SUBSEQUENTLY FAILED ALLOWING THE DETECTOR TO FALL TO THE FLOOR. PICTURES OF THE DEVICE AND THE ACTUAL DETECTOR MOUNTING BOLTS WERE RETURNED FOR EVALUATION. A VISUAL EXAMINATION OF THE BOLTS INDICATE WEAR CONSISTENT WITH A LOOSE INTERFACE. FURTHER, IT IS POSSIBLE THAT LOOSENING OF THE BOLTS WAS ACCELERATED BY LACK OF LOCTITE ON THE BOLTS. UPON REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CUSTOMERS ARE WARNED THAT DURING TRANSPORTATION THE COLUMN MUST BE IN ITS LOWEST POSITION. ALL POWER CABLES MUST BE ROLLED ONTO THE CABLE ROLL. ADDITIONALLY, THE IFU STATES THE FOLLOWING: ENTER ELEVATORS WITH THE GANTRY FORWARD AND PULL THE TRANSCAM BACKWARD TO EXIT. IF THERE IS A SAG IN THE ELEVATOR BELOW THE LEVEL OF THE FLOOR, THE LARGER WHEELS WILL MAKE EXITING MUCH EASIER. AS SPECIFIED IN MFG DOCUMENTS, (TRANSCAM ASSEMBLY MANUAL - NOVEMBER 1998) LOCTITE IS APPLIED TO THE BOLTS THAT MOUNT THE DETECTOR TO THE DETECTOR ARM. THE PHILIPS' SERVICE RECORD FROM (B)(4) 2004, STATED THAT BOLTS WERE FOUND LOOSE ON ONE SIDE OF THE DETECTOR. NEW BOLTS WERE SUBSEQUENTLY INSTALLED. WHILE THERE WAS NO DIRECT MENTION OF LOCTITE (RE)APPLICATION IN THE SERVICE RECORD, THE SERVICE MANUAL STATES TO "ALWAYS ADD THREAD-LOCKING FLUID TO ALL BOLTS." (NOTE: VISUAL EXAMINATION OF THE BOLTS WAS INCONCLUSIVE WITH RESPECT TO LOCTITE RESIDUE.) THE SYSTEM HAS BEEN SERVICED BY THIRD-PARTY VENDOR (B)(4) FOR THE PAST 5 YEARS. A REVIEW OF (B)(4) SERVICE RECORDS INDICATE THAT ROUTINE PREVENTIVE MAINTENANCE (PM) HAS BEEN COMPLETED SINCE 2007 WITH THE LAST PM BEING COMPLETED ON (B)(4) 2009. THERE ARE NO REPORTED ISSUES WITHIN THESE SERVICE RECORDS INDICATING A LOOSE DETECTOR OR BOLTS. A (B)(4) SERVICE REPORT, DATED AFTER THIS EVENT ((B)(4) 2010), STATES THAT A NEW DETECTOR WAS INSTALLED WITH NEW BOLTS AND LOCTITE AND THE SYSTEM RETURNED TO SERVICE. IT IS OUR OPINION THAT A LOOSE DETECTOR AND/OR LOOSE DETECTOR BOLTS SHOULD HAVE BEEN DETECTED (AND CORRECTED) DURING THE LAST PM. INTERNAL CROSS REFERENCE: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE DETECTOR FELL OFF THE GANTRY AND ON TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSCAM TRANSCAM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 5200-2338

    Patients

    Seq Age Sex Outcome Treatment
    1