Description of Event or Problem · 1
THE RPTR WAS RETAINED BY ANOTHER MFR TO CONDUCT AN OPERATIONAL/FUNCTIONAL ANALYSIS AND COMPARISON OF THE VASOMEDICAL, INC EECP MODEL MC2 AND THE OTHER MFR'S MODEL 3000 CARDIASSIST, EXTERNAL COUNTERPULSATION DEVICES. THE RPTR USED CALIBRATED INSTRUMENTS AND ENGINEERING TESTING ANALYSIS FOR THIS INVESTIGATION OF THE VASOMEDICAL, INC EECP MODEL MC2 AND THE MODEL 3000 CARDIASSIST EXTERNAL COUNTERPULSATION DEVICES. A CUSTOM TEST PROGRAM WAS SET UP, WHEREBY THEY COULD COMPARE THE FUNCTIONALITY OF THE TWO DEVICES. HOWEVER, ONCE INVOLVED IN THE COMPARISON INVESTIGATION, MAJOR CONSTRUCTIONAL AND FUNCTIONAL ERRORS IN ADDITION TO PT AND USER SAFETY ISSUES BECAME APPARENT WITH THE VASOMEDICAL, INC EECP MODEL MC2 DEVICE. FIRST, BEING ETHICALLY BOUND AS AN ELECTRICAL ENGINEER (BSEE), AND SECOND AS A PRODUCT SAFETY ENGINEER, RPTR IS CONSTRAINED BY ETHICAL OBLIGATION, TO INFORM THE PROPER AUTHORITIES OF THE POTENTIALLY DISASTROUS CONSTRUCTIONAL DEFICIENCIES, AND VIOLATIONS OF THE NATIONAL ELECTRIC CODE MEDICAL DEVICE REQUIREMENTS FOUND IN THE VASOMEDICAL, INC EECP MODEL MC2 DEVICE. THE RPTR'S PRODUCT SAFETY TESTING FACILITY BELIEVES THE CONTROLLING OR ENFORCEMENT AGENCIES CONCERNED WITH PT AND USER/OPERATOR SAFETY MUST BE MADE AWARE OF THE PT AND OPERATOR SHOCK HAZARDS OBSERVED. IN ADDITION TO THE SHOCK HAZARDS, THE DEVICE IS IN VIOLATION OF THE NEC CODE. NEC CODE REQUIRES CERTIFIED COMPONENTS BY A NATIONALLY RECOGNIZED TEST LAB. THE DEVICE USES ALL UNCERTIFIED COMPONENTS IN THE PRIMARY AND SAFETY RELATED CIRCUITS. DEFICIENCIES WERE FOUND THROUGHOUT THE VASOMEDICAL, INC EECP MODEL MC2 FOUR MAIN COMPONENTS: THE ELECTRICAL CONTROL UNIT, THE AIR CONTROL/DISTRIBUTION UNIT, THE COMPRESSOR UNIT AND THE BED. RPTR BRIEFLY DESCRIBES THE ELECTRICAL CODE DEFICIENCIES UNDER THE UNIT TO WHICH THEY PERTAIN. CONTROL BOX: 1) PT LEADS HAVE UP TO 966U A LEAKAGE CURRENT, THE OTHERS BEING 740U A. PT IS DIRECTLY GROUNDED. 2) ALL UNAPPROVED COMPONENTS IN CRITICAL PRIMARY - PT ISOLATION: TRANSFORMERS, BOTH HV OPTO-TRANSFORMER (18KV) AS WELL AS ALL OF THE OTHER ISOLATION TRANSFORMERS USED. 3) POWER SWITCH IS UNAPPROVED AND NOT GROUNDED. 4) ALL SWITCHES IN THE PRIMARY CIRCUIT ARE UNAPPROVED. 5) GROUND WIRE IS THE WRONG SIZE (UNDER SIZED), NOT PROPERLY SITUATED, MOUNTED OR MARKED. OVERALL GROUND FOR CHASSIS IS ON TOP OF A STACKED GROUND LUG. 6) FUSING IS UNAPPROVED; FUSE HOLDERS ARE LOOSE AND CAN BE REMOVED BY HAND. 7) PCB FLAMMABILITY IS UNAPPROVED AND THE SPACING REQUIREMENTS ARE INSUFFICIENT. 8) THERE ARE HOLES IN THE BOTTOM OF THE UNIT, DIRECTLY UNDER HIGH VOLTAGE COMPONENTS. 9) HIGH AND LOW VOLTAGE WIRING IS NOT ROUTED CORRECTLY. 10) INPUT POWER PLUGS ARE UNAPPROVED. 11) THE CATHODE RAY TUBE IS UNAPPROVED AND IS POWERED BY 18KV LOCATED ON THE SAME PCB AND NEAR PT ISOLATION LEAD OUTPUTS. 12) 110-VOLT FAN IS UNAPPROVED. 13) EMERGENCY LOCK-OUT CIRCUITRY IS NONFUNCTIONAL. WHEN THE TOP OF THE UNIT IS REMOVED, THE SAFETY SWITCH, WHICH SHOULD DISABLE POWER, DOES NOT FUNCTION. THE CIRCUITRY IS ALSO UNCERTIFIED. AIR CONTROL UNIT: 1) EMERGENCY STOP SWITCH IS UNAPPROVED AND IS MUSHROOMED. MUSHROOMED SWITCHES ARE NOT APPROVED. 2) TRANSFORMER IS UNAPPROVED. 3) RELAY UNAPPROVED. 4) DIODE BRIDGE IS UNAPPROVED. 5) ALL SWITCHES ARE UNAPPROVED. 6) GROUND IS THE WRONG SIZE AND IMPROPERLY MOUNTED. 7) UNSATISFACTORY SOLDER TECHNIQUES ARE USED ON UNDERSIDE OF TRANSFORMER BOARD. 8) POWER IN/POWER OUT RECEPTACLES ARE UNAPPROVED. 9) WIRES ARE UNCERTIFIED. 10) BUSHING FOR WIRE IS UNAPPROVED. FURTHERMORE CHAFING CAN OCCUR, CREATING A SHOCK HAZARD. 11) FOAM INSULATION APPEARS TO BE UNAPPROVED. COMPRESSOR UNIT: 1) POWER OUT CONTROL CONNECTOR IS BROKEN AND UNCERTIFIED. IT CAN BE HAND REMOVED LEAVING A 110-VOLT POTENTIAL EXPOSED. 2) GROUND RUNS THE LENGTH OF THE CHASSIS AND IS NOT PROPERLY MOUNTED OR MARKED. 3) GE MOTOR HAS NO UL APPROVAL. 4) TRANSFORMER IS UNAPPROVED. 5) INTERNAL FANS ARE 110-VOLTS, USING UNCERTIFIED WIRING WITH SPLICES EXPOSING ENDS AT 110-VOLT POTENTIAL. 6) ALL WIRING IS UNAPPROVED AND USES THE WRONG COLOR CODE. 7) FOAM INSULATION IS UNAPPROVED. THE BED: 1) ALL 110-VOLT PRESSURE TRANSDUCERS ARE UNAPPROVED. 2) 110-VOLTS IS APPLIED TO THE PT BED AND THE BED IS GROUNDED. 3) ALL WIRES ARE UNCERTIFIED. 4) FOAM INSULATION IS UNCERTIFIED. RPTR WRITES, "IN ALMOST EVERY AREA OF SAFETY THE VASOMEDICAL, INC EECP MODEL MC2 IS DEFICIENT. THE DEVICE WOULD NEED A MAJOR CONSTRUCTIONAL REWORK IN ORDER TO BE COMPLIANT WITH THE NATIONAL ELECTRIC CODE SUCH AS THE USE OF PRIMARY AND SAFETY RELATED COMPONENTS TESTED AND APPROVED BY A NATIONALLY RECOGNIZED TEST LAB AS REQUIRED BY THE NEC. GROSS DEFICIENCIES WERE NOTED, THE MOST SERIOUS BEING THAT THE PT IS NOT ISOLATED FROM HIGH VOLTAGE OR CURRENT. THIS CREATES AN EXTREMELY DANGEROUS SITUATION FOR THE PT AS WELL AS THE OPERATOR. IT IS RPTR'S RECOMMENDATION, AS AN ENGINEER CONCERNED ONLY WITH THE SAFETY ASPECTS OF THE DEVICE, THAT THIS PARTICULAR DEVICE BE REMOVED IMMEDIATELY FROM SVC WITHIN THE UNITED STATES."