INGENUITY TF PET/MR
Received Oct 19, 2020 · Event occurred Oct 5, 2020
Report 3015777306-2020-00017 · MDR key 10700380
Device
Generic name
Tomographic Imager Combining Emission Ct With Nulear Mr
Manufacturer
Philips Medical Systems Nederland B.v.Model number
INGENUITY PET/MRCatalog number
882380
Product problems
- Unintended System Motion
- Unintended System Motion
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ON (B)(6) 2020, (B)(6). NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: (B)(4).
Description of Event or Problem
THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THAT PET/MR TABLE DID NOT STOP AT THE REQUESTED POSITION. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT.
Description of Event or Problem
THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THAT PET/MR TABLE DID NOT STOP AT THE REQUESTED POSITION. THE SYSTEM WAS IN CLINICAL USE WHEN THIS EVENT OCCURRED. THERE WAS NO REPORT OF HARM. BASED ON THE PROVIDED INFORMATION, THIS ISSUE HAS BEEN DETERMINED NOT TO BE A REPORTABLE EVENT.
Additional Manufacturer Narrative
THE ISSUE REPORTED WAS THAT PET/MR TABLE DID NOT STOP AT THE REQUESTED POSITION. THE SYSTEM WAS IN CLINICAL USE WHEN THIS EVENT OCCURRED. THERE WAS NO REPORT OF HARM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO EVALUATE AND CONFIRM THE REPORTED ISSUE. PER THE FSE, THE CUSTOMER USES A LIGHT-VISOR TO POSITION THE PATIENT IN THE BORE OF THE MR SCANNER. THE CUSTOMER DOES THIS POSITIONING BY USING A TUMBLE SWITCH TO MOVE THE PATIENT INSIDE THE BORE. NORMAL OPERATION IS THE TABLE STOPS AT THE POINT THE LIGHT-VISOR IS SET. HOWEVER, IN THIS EVENT, THE TABLE MOVED OVER THIS POINT. THE FSE CONFIRMED THAT WHEN THE CUSTOMER RELEASED THE TUMBLE SWITCH THE TABLE AUTOMATICALLY STOPPED. THE FSE REVIEWED LOGFILES AND DETERMINED THE HORIZONTAL ENCODER HAD FAILED. THE FAILED PART WAS REPLACED, AND THE TABLE WAS CALIBRATED TO RESOLVE THE ISSUE. THE SYSTEM WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. PROBABLE CAUSE : FAULTY HORIZONTAL ENCODER. THIS EVENT IS NOT REPORTABLE. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4).