ICT
Report
- Report Number
- 1525965-2015-00237
- Event Type
- Malfunction
- Date Received
- September 2, 2015
- Report Date
- August 14, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K060937
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
(B)(4). NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).
ON 14-AUG-2015, THE CUSTOMER REPORTED UNCOMMANDED VERTICAL MOTION WHEN UTILIZING THE FREE FLOAT PEDAL ON THE MULTIFUNCTION FOOTSWITCH (MFFS). A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR, OR BYSTANDER. THE FSE REPORTED THAT WHEN DEPRESSING THE FREE FLOAT PEDAL ON THE MFFS, IT CAUSED THE TABLE TO TRAVEL UPWARD. THE FSE EVALUATED THE SYSTEM AND DETERMINED THAT THE MFFS COVER WAS INTERFERING WITH THE UP PEDAL CAUSING IT TO BECOME STUCK ENGAGED. THE PHILIPS FSE WAS CONTACTED AND IT WAS COMMUNICATED THAT WHEN THIS EVENT OCCURRED, THE UNCOMMANDED MOTION WAS STOPPED WHEN THE OPERATOR WOULD RELEASE THE FOOT PEDAL ON THE MFFS. THERE WERE NO PARTS REPLACED AND NO SYSTEM LOGFILES PROVIDED FOR EVALUATION. THE PHILIPS FSE ADJUSTED THE POSITION OF THE FOOTSWITCH COVER TO RESOLVE THE REPORTED ISSUE. CT ENGINEERING DETERMINED THIS TO BE AN ACCEPTABLE RISK. THE FOLLOWING MITIGATIONS FOR THIS ISSUE INCLUDE: A. STOPPING HORIZONTAL MOTION IN THE PRESENCE OF RESISTANCE FORCE (NOT APPLICABLE FOR VERTICAL); B. TABLE COLLISION ENVELOPE; C. SINGLE FAULT SAFE AGAINST UNCONTROLLED MOTION: ¿ HORIZONTAL NODE WATCHDOG TIMER. IF MAXIMUM TIME OF CONTROL RESPONSE IS EXCEEDED, E-STOP WILL BE ACTIVATED. ¿ DOUBLE SWITCHES ON CONTROL BUTTONS PROVIDES REDUNDANCY SUCH THAT 2 SWITCHES MUST BE ACTIVATED BEFORE A MOTION IS EXECUTED D. DESIGN MITIGATIONS ENABLING HUMAN RESPONSE: ¿ CONTINUOUS ACTIVATION FOR MANUAL MOTION; ¿ EMERGENCY STOP CONTROLS ENABLE TERMINATION OF MOTION IN HAZARDOUS CONDITION; ¿ EMERGENCY POWER OFF SWITCH SUPPLIED WITH SYSTEM OR SITE INSTALLATION ENABLES THE OPERATOR TO SHUT OFF POWER TO THE ENTIRE SYSTEM. ¿ SPEED OF MOTORIZED NON-PROGRAMMED MOTION IS LIMITED. THE PHILIPS FSE ADJUSTED THE MULTIFUNCTION FOOTSWITCH COVER TO RESOLVE THIS ISSUE. BASED ON THE INFORMATION PROVIDED, THE PROBABLE CAUSE WAS DUE TO PEDAL INTERFERENCE WITH THE COVER ON THE MULTIFUNCTION FOOTSWITCH.
THE CUSTOMER REPORTED UNCOMMANDED, VERTICAL MOTION WHEN UTILIZING THE FREE FLOAT PEDAL ON THE MULTI-FUNCTION FOOT SWITCH (MFFS). A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR, OR BYSTANDER. THE FSE REPORTED THAT WHEN DEPRESSING THE FREE FLOAT PEDAL ON THE MFFS, IT CAUSED THE TABLE TO TRAVEL UPWARD. THE FSE EVALUATED THE SYSTEM AND DETERMINED THAT THE MFFS COVER WAS INTERFERING WITH THE UP PEDAL CAUSING IT TO BECOME STUCK ENGAGED. THE FSE ADJUSTED THE POSITIONING OF THE MFFS COVER TO RESOLVE THIS ISSUE.
THE CUSTOMER REPORTED UNCOMMANDED, VERTICAL MOTION WHEN UTILIZING THE FREE FLOAT PEDAL ON THE MULTI-FUNCTION FOOT SWITCH (MFFS). A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR, OR BYSTANDER. THE FSE REPORTED THAT WHEN DEPRESSING THE FREE FLOAT PEDAL ON THE MFFS, IT CAUSED THE TABLE TO TRAVEL UPWARD. THE FSE EVALUATED THE SYSTEM AND DETERMINED THAT THE MFFS COVER WAS INTERFERING WITH THE UP PEDAL CAUSING IT TO BECOME STUCK ENGAGED. THE FSE ADJUSTED THE POSITIONING OF THE MFFS COVER TO RESOLVE THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 582347 | ICT | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728306 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |