LEOPARD SPINCE COIL 1.5T
Report
- Report Number
- 1056069-2019-00002
- Event Type
- Malfunction
- Date Received
- September 27, 2019
- Report Date
- August 30, 2019
- Manufacturer
- CARMA SALUD, S.L.
- Product Code
- MOS
- PMA / PMN Number
- K122897
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, TU
- Reporter Occupation
- OTHER
Narratives
A LEOPARD SPINE COIL WAS DELIVERED TO INVIVO'S SERVICE & REPAIR DEPARTMENT ON AUG 15 2019. WHEN THE REPAIR TECH RECEIVED THE COIL INTO REPAIR, THEY NOTICED THAT THERE WAS EVIDENCE OF A MELTED SPOT ON THE COIL HOUSING IN AN AREA THAT COULD BE IN CONTACT WITH A PATIENT IF NO PADDING BETWEEN PATIENT AND COIL WERE BEING USED, WHICH IS INDUSTRY STANDARD PRACTICE. THE DISTRIBUTOR GAVE NO INDICATION OF HARM OR POTENTIAL HARM TO PATIENT WHEN THEY RETURNED THE DEVICE. THE TECH CONTACTED Q&R FOR FURTHER ANALYSIS AND UPON REVIEW, IT WAS DETERMINED THAT AN ENGINEERING EVALUATION WOULD BE REQUIRED, AND ALTHOUGH THERE WAS NO INDICATION OF SERIOUS INJURY, A CONSERVATIVE DECISION WAS MADE TO REPORT THE ISSUE TO THE COMPETENT AUTHORITIES (FDA). THE SERVICE DEPARTMENT DETERMINED THAT THE COIL WAS IN NO CONDITION TO BE USED IN THE FIELD AGAIN AND THE COIL WAS SCRAPPED OUT IN THE ERP SYSTEM AND COULD EVER BE DELIVERED BACK OUT TO THE FIELD. THE DEVICE INVESTIGATION/ANALYSIS WAS CONDUCTED. INITIAL VISUAL EXAMINATION REVEALED THAT THERE WAS A CLEAR SIGN OF OVERHEATING ON THE TOP SURFACE OF THE COIL. THE COIL WAS OPENED AND THE INTERIOR WAS INSPECTED TO CHECK THE CAUSE OF DAMAGE. IT WAS OBSERVED THAT AN OVER CURRENT SITUATION OCCURRED AT THE SITE WHERE THE PLASTIC HOUSING APPEARED BURNED. ALSO, THE INTERFACE BETWEEN THE SYSTEM CABLE AND THE COIL STRAIN RELIEF IS HEAVILY DAMAGED SHOWING SIGNS OF EXTREME USE. THE ENDS ARE ALSO HELD TOGETHER USING SOME MEDICAL TAPE, AND THE RF LINES ARE EXPOSED. THOUGH THIS IS NOT A CAUSE OF THE HEATING PROBLEM, THE POWER AND RF LINES ARE SUSCEPTIBLE TO DAMAGE QUICKER. THE SYSTEM CONNECTOR HAS SIGNS OF HEAVY USE AS THE CABLE IS BROKEN AT THE CONNECTOR AND IS HELD TOGETHER WITH TAPE. THERE IS ALSO A SCREW MISSING IN THE CONNECTOR, WHICH INDICATES THAT THE CONNECTOR WAS OPENED EITHER BY A PHILIPS FSE OR BY SOMEONE FROM THE HOSPITAL OR A THIRD PARTY REPAIR HOUSE UNAUTHORIZED BY INVIVO OR PHILIPS. INSPECTION INSIDE THE SYSTEM CONNECTOR REVEALED THAT ALL THE RF LINES INSIDE THE CONNECTOR APPEAR FRAYED. THE CRIMPS DO NOT SEEM TO HAVE BEEN WELL CONNECTED. MORE INTERESTINGLY, THE CABLE ON RF-1 HAS BEEN ¿FIXED¿ WITHOUT OUR KNOWLEDGE. THE CABLE RF-1 HAS BEEN REPLACED. SEVERAL MODIFICATIONS WERE OBSERVED ON RF-1. A DIFFERENT RF LINE IN THE CABLE BUNDLE WAS USED BY SPLICING THIS CABLE AT MULTIPLE POINTS. FURTHER INTERNAL COIL INSPECTION SHOWS THAT DECOUPLERS AROUND LOOP 16, WERE MOVED AND THE CONNECTORS THAT WERE PRESENT WERE REMOVED. INSTEAD, THE DECOUPLERS ARE NOW HELD WITH BUSS WIRE, AND A JUMPER WIRE HAS BEEN SOLDERED, IN ORDER TO SUPPLY POWER. UNFORTUNATELY, THE THIRD-PARTY COMPANY MAKING THESE CHANGES MOVED AND PLACED ¿MIRRORED¿ TYPE DECOUPLERS IN ¿NON-MIRRORED¿ LOCATIONS. THE DECOUPLERS, THEN, WERE ONLY OPERATING IN THE PASSIVE MODE OF OPERATION. THE PASSIVE MODE OF OPERATION IS A FAIL-SAFE MODE OF OPERATION AND THE COIL IS NOT SUPPOSED TO BE OPERATED UNDER THIS CONDITION FOR LONG PERIODS OF TIME. THE UNAUTHORIZED REPAIR ALSO BYPASSED THE MALFUNCTION DETECTION CIRCUIT THAT WOULD HAVE BEEN TRIGGERED WHEN THE DECOUPLERS WERE WORKING IN PASSIVE MODE. ALL THE BALUNS HAVE FAILED IN THE COIL AND SHOW SIGNS OF ARCING NEAR THE CAPACITORS. BALUN 1 IS CLOSE TO THE DAMAGED LOOPS HAS BEEN REASSEMBLED INCORRECTLY. IN THIS CONFIGURATION, THE BALUN WILL NOT FUNCTION. SOMEONE OUTSIDE INVIVO MADE THIS CHANGE. THE SECOND AND THIRD BALUN HAVE CRACKED SOLDER AROUND THE CAPACITORS AND SHOW SIGNS OF ARCING. FINALLY, AT THE AREA WHERE THE PLASTIC LOOKED DEFORMED IT IS SEEN THAT THERE IS SEVERE DAMAGE TO THE ORIGINAL FR-4 PCBA. IT SHOULD BE NOTED THAT THE INPUT BOARD HAS BEEN REPLACED WITH AN UNAPPROVED AND OFF THE SHELF ¿BREAD BOARD¿ FOR PLACING THE PREAMP. THIS IS UNADVISABLE AS THE BREAD BOARD WITHOUT SILK SCREEN CANNOT PROTECT AGAINST ARCING UNDER HIGH VOLTAGE CONDITIONS AND SHOULD NOT HAVE BEEN PLACED. IT IS ALSO OBSERVED THAT SEVERAL TRACES WERE FIXED WITH JUMPER WIRES. ADDITIONALLY, IT IS NOTED THAT THE INPUT BOARD HAS A HOLE IN ITS PCBA. THIS HOLE APPEARS TO BE CAUSED BY A BURN AND REPAIRED. THE INPUT BOARD AT CHANNEL 13 WAS BURNT, SHOWING SIGNS OF OVERVOLTAGE. THE BOARD HAS BEEN MODIFIED WITH A WHITE JUMPER WIRE. SEVERAL MODIFICATIONS TO THE COILS ELECTRONICS AND SAFETY DEVICES WERE OBSERVED. NONE OF THESE MODIFICATIONS ARE OR WERE AUTHORIZED BY INVIVO. ALL FINAL BENCH TESTS WERE CONDUCTED AND DOCUMENTED IN THE REPORT. FROM THE TEST RESULTS IT IS SEEN THAT THE COIL CAN FUNCTION INSIDE THE MRI SYSTEM, AND WILL NOT CAUSE A MALFUNCTION, ONLY BECAUSE THE MALFUNCTION DETECT CIRCUIT HAS BEEN BYPASSED. IN ADDITION, ALL THE LOOPS ARE SLIGHTLY MISTUNED AND ARE OFF FREQUENCY. THIS CAN BE DUE TO THE FACT THAT THREE OF THE INTERNAL BALUNS ARE NO LONGER WORKING WHICH VARIES THE STRUCTURE OF THE LOOP ELEMENTS AND CAUSE THE TUNING TO DRIFT. THE EXTERNAL BALUN ON THE SYSTEM CABLE HAS BEEN INSPECTED INTERNALLY AND EXTERNALLY. THERE WERE NO SIGNS OF DAMAGE ON THE EXTERNAL BALUN BUT IT WAS NOTICED THAT THE SYSTEM CABLE HAD BEEN MODIFIED AND A BALUN HAD BEEN REMOVED. ALL THE DRAWINGS SHOW THAT THE SYSTEM CABLE IS SUPPOSED TO HAVE TWO BALUNS BUT ONLY ONE BALUN IS PRESENT ON THE RETURNED PRODUCT. IT IS OBSERVED THAT THE CABLE IS LONGER THAN IT IS IN THE CURRENT DRAWING. THE CABLE BALUN HAS BEEN REMOVED AND THE CABLE HOSE HAS BEEN REMOVED. THIS IS ALSO THE REASON WHY THE CABLES HAVE BEEN SPLICED. IN SUMMARY, THIS COIL HAS BEEN MODIFIED IN AN UNAUTHORIZED MANNER, LIKELY BY AN UNAUTHORIZED AND UNQUALIFIED SOURCE, AND THE COIL IS NO LONGER CONFORMING TO ITS MANUFACTURING SPECIFICATIONS. THE BALUN AND DECOUPLERS ARE SAFETY CIRCUITS THAT PREVENT THE BUILD-UP OF LARGE CABLE CURRENTS AND PROTECT BOTH THE PATIENT AND THE ELECTRONICS IN THE COIL AGAINST THE LARGE TRANSMIT POWER OF THE MRI SYSTEM. DUE TO THE UNAUTHORIZED MODIFICATIONS IT IS SEEN THAT THE SYSTEM CABLE BALUN HAS BEEN REMOVED, THE FIRST INTERNAL BALUN HAS BEEN REMOVED AND ASSEMBLED INCORRECTLY, RENDERING IT USELESS. EVENTUALLY IT PUT A LOT OF STRESS ON THE TWO REMAINING INTERNAL BALUNS CAUSING THEM TO FAIL DUE TO HIGH VOLTAGES. WITHOUT ANY BALUNS, LARGE CURRENTS CAN BE FORMED ON THE INTERNAL CABLE AND INTERACT WITH THE LOOP ELEMENTS. THIS IN TURN CAUSED THE BURNED FR-4 AND DAMAGE TO THE PCBA. ALL OF THIS IS FURTHER EXASPERATED BY THE IMPROPER PLACEMENT OF DECOUPLERS. THIS DAMAGE IS A RESULT OF THE GROSS UNAUTHORIZED MODIFICATIONS MADE TO THE COIL. PLEASE NOTE: THE RESULTS CODES (C92122 ¿ THERMAL PROBLEM, AND C92045 ¿ ELECTRICAL PROBLEM) AND CONCLUSION CODE (C91880 ¿ CAUSE TRACED TO MAINTENANCE) SEEMED THE MOST APPROPRIATE CODES FOR THE INVESTIGATION, EVEN THOUGH IT APPEARS THE MAINTENANCE WAS PERFORMED BY AN UNAUTHORIZED SOURCE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
THE INVESTIGATION IS STILL ONGOING FOR THIS EVENT. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
A LEOPARD SPINE WAS DELIVERED TO THE REPAIR FACILITY, WHEN THE REPAIR TECH STARTED THE REPAIR PROCESS, INVIVO TECHNICIAN DISCOVERED THE HOUSING OF THE COIL WAS WARPED (FROM HEATING) IN AN AREA THAT COULD POTENTIALLY BE IN CONSTANT CONTACT WITH THE PATIENT. INITIAL INVESTIGATION INDICATES THAT AT SOME POINT THIS COIL WAS ALTERED WHERE MULTIPLE SAFETY MECHANISMS WERE BYPASSED. THIS ALTERATION WAS DONE WITHOUT AUTHORIZATION BY INVIVO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 926143 | LEOPARD SPINCE COIL 1.5T | LEOPARD SPINE COIL 1.5T | MOS | CARMA SALUD, S.L. | 9896-032-07901 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |