BEUDAMED
    FDA Adverse Event Other Summary report: N

    IRIX SPECT SYSTEM

    MDR report key: 2492472 · Received March 8, 2012

    Report

    Report Number
    1525965-2012-00007
    Event Type
    Other
    Date Received
    March 8, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 22, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K964712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER INSPECTED THE SYSTEM AND PERFORMED TESTS REGARDING THE REPORTED EVENT. THE LATCH POSITION BOARD WAS VERIFIED TO BE FUNCTIONING CORRECTLY. THE LATCHINGS OF ALL CUSTOMER COLLIMATORS WERE VERIFIED TO BE FUNCTIONING CORRECTLY. ALL EXCHANGE COLLIMATORS WERE VERIFIED TO BE FUNCTIONING CORRECTLY. THE FIELD SERVICE ENGINEER REPLACED THE DETECTOR HEAD BEZEL COVER WHICH RESOLVED THE INTERMITTENT COLLISION ERRORS. THE COLLIMATOR FALLING WAS DETERMINED TO BE USER ERROR AND NOT DUE TO THE MALFUNCTION RELATING TO THE COLLISION ERRORS. IN AN ATTEMPT TO CLEAR THE COLLISION ERRORS, THE TECHNOLOGIST TOOK MEASURES OUTSIDE OF WHAT IS DOCUMENTED IN THE IRIX USER'S GUIDE (453567909031 REV.B) REGARDING INSTRUCTIONS TO CORRECTLY PERFORM COLLIMATOR EXCHANGES (SECTION 3). IN ADDITION, THE FOLLOWING WARNINGS ARE DOCUMENTED IN THE IRIX'S USER'S GUIDE: EQUIPMENT SAFETY (SECTION 2 PAGE 2-18). "ALWAYS INSPECT THE SYSTEM FOR HAZARDOUS CONDITIONS OR EQUIPMENT MALFUNCTIONS PRIOR TO OPERATION. WATCH FOR ABNORMAL OR INCONSISTENT CAMERA CONTROL OPERATION, SUCH AS INTERMITTENT PUSHBUTTON OPERATION OR INTERLOCK SWITCH FAILURE." "UPON DISCOVERY OF IMPROPER CONDITIONS OR EQUIPMENT MALFUNCTIONS, REFER THE PROBLEM TO QUALIFIED SERVICE PERSONNEL IMMEDIATELY." "ALWAYS MAKE SURE THAT COLLIMATORS ARE INSTALLED SECURELY." IRIX EXCHANGING AND STORING COLLIMATORS (SECTION 3 PAGE 3-32) 9". VERIFY THAT THE LATCHING PINS ON THE COLLIMATOR ARE ALIGNED WITH THE HOLES IN THE DETECTOR HEAD." "WARNING: EQUIPMENT HAZARD. MISALIGNMENT CAN CAUSE DAMAGE. IF THE COLLIMATOR DOES NOT ALIGN CORRECTLY WITH THE DETECTOR HEAD, STOP ALL MOTION IMMEDIATELY AND CONTACT YOUR FIELD SERVICE REP. FAILURE TO COMPLY WILL RESULT IN BODILY INJURY AND/OR EQUIPMENT DAMAGE." "ERROR MESSAGE: COLLIMATOR ON HEAD <1, 2 3> SUDDENLY BECAME UNLATCHED CORRECTIVE ACTION: CONTACT LOCAL FIELD SERVICE." (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. THE TECHNOLOGIST WAS PERFORMING QUALITY CONTROL ON THE SYSTEM, WHICH WAS EXPERIENCING REPEATED COLLISION ERRORS. THE TECHNOLOGIST ATTEMPTED TO RESOLVE THE COLLISION ERRORS BY PRESSING THE TWO LOCKING LUGS OF THE COLLIMATOR, WITH A PEN, WHILE IT WAS NOT WELL LATCHED. THE POSITION OF THE DETECTOR WAS ALMOST VERTICAL AND DUE TO THE PRESSURE FROM THE TECHNOLOGIST ON THE COLLIMATOR AND THE ROTATION OF THE GANTRY CONTROLLED BY THE TECHNOLOGIST, THE COLLIMATOR SLIPPED AND FELL TO THE GROUND. NO ONE WAS INJURED AS A RESULT OF INJURED COLLIMATOR FALLING. THE COLLIMATOR WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRIX SPECT SYSTEM EMISSION COMPUTED TOMOGRAPHY SYSTEM KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 211281

    Patients

    Seq Age Sex Outcome Treatment
    1