BRILLIANCE 16 AIR
Report
- Report Number
- 1525965-2015-00196
- Event Type
- Injury
- Date Received
- July 14, 2015
- Report Date
- July 7, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K012009
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
(B)(4). ON (B)(4) 2015, A FSE WAS INJURED WHILE PERFORMING FCO 72800625 (VERTICAL DRIVE SHAFT ADHESION) ON THE BRILLIANCE 16 SLICE CT SYSTEM AT (B)(4). THE FSE (FIELD SERVICE ENGINEER) WAS ATTENDING THE SITE TO PERFORM FIELD CORRECTION ON THE SYSTEM. THE EVENT OCCURRED IN THE FOLLOWING ORDER: 1. THE FSE BEGAN IMPLEMENTATION OF FIELD CORRECTION. 2. THE FSE FORGOT TO INSTALL THE GREEN VERTICAL SAFETY SUPPORT BRACE. 3. THE FSE REMOVED THE 4 BOLTS HOLDING THE VERTICAL MOTOR/BRAKE 4. THE PATIENT SUPPORT COLLAPSED 5. THE FSE'S HANDS WERE HIT AND TRAPPED BY THE PATIENT SUPPORT. 6. THE HOSPITAL'S EMERGENCY TEAM RAISED THE PATIENT SUPPORT TO EXTRACT THE FSE FROM THE SYSTEM. THE FSE WAS CLINICALLY EVALUATED BY A PHYSICIAN AND X-RAY IMAGING WAS PERFORMED ON THE FSE'S HANDS. THE FSE THEN HAD SURGERY TO RECONSTRUCT HIS RIGHT INDEX FINGER. A DIFFERENT FSE ATTENDED THE SITE FOR COMPLETION OF THE FIELD CORRECTIONS. THE PATIENT SUPPORT WAS RAISED UTILIZING A FORKLIFT AND THE GREEN VERTICAL SAFETY SUPPORT BRACE WAS INSTALLED PROPERLY. THE FIELD CORRECTIONS WERE THEN IMPLEMENTED SUCCESSFULLY. THE SERVICE INSTRUCTIONS/PROCEDURE FOR FCO 72800625 LISTS 3 SEPARATE WARNINGS IN REGARDS TO THE USE OF THE VERTICAL SAFETY SUPPORT BRACE: WARNING INSTALL THE VERTICAL SAFETY SUPPORT BRACE WHENEVER PERSONNEL ARE WORKING UNDER THE TABLE. FAILURE TO DO SO MAY RESULT IN PERSONNEL INJURY OR DEATH. WARNING MAKE SURE THAT THE VERTICAL SAFETY SUPPORT IS CORRECTLY INSTALLED BEFORE REMOVING THE VERTICAL DRIVE MOTOR TO PREVENT THE SUPPORT TOP FROM DROPPING. WHEN THE VERTICAL MOTOR IS REMOVED, THE PATIENT SUPPORT VERTICAL DRIVE IS UNCONTROLLED AND FREE TO FALL QUICKLY. FAILURE TO COMPLY MAY RESULT IN SERIOUS INJURY OR DEATH TO SERVICE PERSONNEL. WARNING: DO NOT ATTEMPT TO LOWER THE PATIENT SUPPORT WITH THE VERTICAL SUPPORT BRACE IN PLACE. LOWERING THE PATIENT SUPPORT WITH THE VERTICAL SUPPORT BRACE IN PLACE WILL DAMAGE THE BALL SCREW DRIVE AND MAY CAUSE SERIOUS INJURY AND/OR DEATH TO SERVICE PERSONNEL. THE BRILLIANCE PATIENT SUPPORT REPAIR AND REPLACEMENT MANUAL REV AG ALSO STATES: WARNING. THE VERTICAL SAFETY SUPPORT BRACE MUST BE INSTALLED WHENEVER PERSONNEL ARE WORKING UNDER THE PATIENT SUPPORT. FAILURE TO DO SO MAY RESULT IN PERSONNEL INJURY OR DEATH. THE FSE'S TRAINING RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT THE FSE HAD RECEIVED OVER 500 HOURS OF ON THE JOB TRAINING WORKING ON THE BRILLIANCE 16 SYSTEM AND PATIENT SUPPORT, BUT HAD NOT COMPLETED THE CLASSROOM TRAINING FOR THE PRODUCT. A PHILIPS SERVICE AND CUSTOMER CARE ANALYST CONFIRMED THAT THE FSE HAD NOT READ THE SERVICE INSTRUCTIONS FOR FCO 72800625 IN IN-CENTER PRIOR TO PERFORMING THE FCO AND AS A RESULT, FORGOT TO INSTALL THE VERTICAL SAFETY SUPPORT BRACE. THE CAUSE OF THIS ISSUE WAS DETERMINED TO BE FSE ERROR (PERFORMING SERVICE ON THE SYSTEM WITHOUT READING THE SERVICE INSTRUCTIONS). CT ENGINEERING EVALUATED THIS ISSUE AND DETERMINED THAT THE OVERALL RISK FOR THIS REPORTED EVENT WAS ACCEPTABLE. PHILIPS PROVIDES SAFETY DOCUMENTATION INCLUDING SPECIFIC SERVICE SAFETY MANUALS AND SECTIONS IN SPECIFIC MAINTENANCE PROCEDURES. SAFETY WHILE PERFORMING SERVICE IS ACHIEVED BY COMPLYING WITH THESE PROCEDURES, ADHERING TO PROVIDED WARNINGS, AND SELECTING THE RECOMMENDED TOOLS FOR THE TASKS. IN ORDER TO INSTALL THE SYSTEM AND REPLACE COMPONENTS THE SERVICE USER IS REQUIRED TO FOLLOW THE PRESCRIBED PROCEDURES, USE THE PROVIDED SAFETY LOCKS AND LIFTING DEVICES (E.G., ROTOR LOCKING PIN, PATIENT SUPPORT VERTICAL SAFETY SUPPORT, AND SPECIAL RIGGING) AND TRAINING TO REDUCE THE PROBABILITY OF HARM CAUSED BY HEAVY PARTS AND ASSEMBLIES BECOMING UNBALANCED, ROTATING, OR FALLING WHILE TRANSPORTING OR INSTALLING THEM. WHEN SERVICE AND SYSTEM INSTALLATION IS PERFORMED SAFELY, USING THE DEFINED PROCEDURES AND TOOLS, THE BENEFITS OUTWEIGH THE POTENTIAL OF HARM FROM MECHANICAL HAZARDS TO THE SERVICE USER. THE HAZARDS ARE MITIGATED BY DESIGN. HOWEVER, THE SERVICE USER HAS THE ABILITY TO DISABLE OR REDUCE THE EFFECTIVENESS OF MITIGATIONS (E.G., REMOVING COVERS OR USING SERVICE MODE ON MOTION CONTROLS). SERVICE USERS ARE SPECIFICALLY TRAINED FOR SERVICING THE SYSTEM IN THESE CONDITIONS AND ARE SUPPLIED WITH SERVICE PROCEDURES. THE TRAINING, ACCOMPANIED BY SYSTEM INTERNAL LABELING AND INSTRUCTIONS REDUCES THE PROBABILITY OF HARM OCCURRING. 1. SAFETY DIRECTIONS IN SERVICE AND TRAINING DOCUMENTATION. 2. SERVICE ONLY BY TRAINED PERSONNEL. 3. TORQUED AND LOC-TITE FASTENERS UNDER CONTROLLED MANUFACTURING PROCEDURES. 4. TEST AFTER INSTALLATION TO VERIFY PROPER MECHANICAL INSTALLATION. 5. COUCH AND GANTRY ARE ANCHORED TO THE FLOOR AND PROPERLY TORQUED. 6. EVERY PART OR ASSEMBLY IS CONNECTED WITH TWO OR MORE SCREWS. 7. SYSTEM CONNECTIONS/ CONNECTORS ARE DESIGNED TO MEET IEC60601-1, CLAUSE 56 REQUIREMENTS. 8. HIGH-POWER, HIGH-VOLTAGE ELECTRICAL CONNECTORS ARE KEYED TO PREVENT IMPROPER INTERCHANGE. 9. LOW-POWER LOW-VOLTAGE ELECTRICAL CONNECTORS EITHER: (1) ARE KEYED TO PREVENT IMPROPER INTERCHANGE, OR (2) ARE DESIGNED SO THAT ANY INTERCHANGE RESULTS IN A SOFTWARE DETECTABLE FAULT CONDITION THAT RESULTS IN A SAFE SYSTEM CONDITION. 10. SYSTEM EMPLOYS LATCHING TYPE CONNECTORS OR PLUGS AND SOCKETS THAT CANNOT SEPARATE FROM NORMALLY EXPECTED VIBRATION. 11. WHEN THE COUCH HAS THE "BEDROCK" CONFIGURATION, THE GEARED MOTOR SHALL HOLD THE COUCH AT MAXIMUM LOAD WHEN THE MOTOR BRAKE IS NOT FUNCTIONAL OR REMOVED. 12. THE SAFETY VERTICAL SUPPORT HAS A BRIGHT COLOR (GREEN) FOR DIFFERENTIATION. THE FSE DID NOT READ THE SERVICE INSTRUCTIONS FOR FCO 72800625 PRIOR TO PERFORMING THE FCO AND AS A RESULT DID NOT PUT THE GREEN VERTICAL SAFETY SUPPORT BRACE IN PLACE BEFORE REMOVAL OF THE VERTICAL MOTOR/BRAKE.
(B)(4). INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4).
THE PHILIPS FIELD SERVICE ENGINEER (FSE) WAS PERFORMING SERVICE ON THE CT SYSTEM AND DID NOT INSTALL THE SAFETY BAR. AFTER REMOVING THE FOUR SCREWS HOLDING THE MOTOR IN PLACE THE CT COUCH COLLAPSED AND THE FSE INJURED HIS RIGHT INDEX FINGER, AND REQUIRED SURGERY.
THE PHILIPS FIELD SERVICE ENGINEER (FSE) WAS PERFORMING SERVICE ON THE CT SYSTEM AND DID NOT INSTALL THE SAFETY BAR. AFTER REMOVING THE FOUR SCREWS HOLDING THE MOTOR IN PLACE THE CT COUCH COLLAPSED AND THE FSE INJURED HIS RIGHT INDEX FINGER, AND REQUIRED SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456186 | BRILLIANCE 16 AIR | COMPUTED TOMOGRAPHY X-RAY | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728246 | - |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |