BRILLIANCE
Report
- Report Number
- 3008581796-2024-00001
- Event Type
- Malfunction
- Date Received
- January 25, 2024
- Date of Event
- August 25, 2023
- Manufacturer
- PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.
- Product Code
- JAK
- UDI-DI
- 00884838095168
- PMA / PMN Number
- K171850
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
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: COMPLAINT (B)(4).
THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; IT WAS REPORTED THAT THE CT SERIES RECONSTRUCTED WITH A X OR Y RECONSTRUCTION OFFSET PER DICOM PRIVATE TAG (01F1,100C), WHICH CAN BE USED WITHIN TUMOR LOC TO TRANSMIT INVALID ABSOLUTE MARKING COORDINATES TO A LASER MARKING SYSTEM. THIS ISSUE WAS IDENTIFIED DURING THE PHILIPS INTERNAL TESTING PROCESS WITHOUT PATIENT INVOVLEMENT. NO SIMILAR ISSUE HAS BEEN REPORTED BY THE CUSTOMER. PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INVESTIGATION RESULT, THIS ISSUE ONLY OCCURS WHEN THERE IS A RECON OFFSET IN X OR Y, IT WILL NOT OCCUR WHEN A RECON OFFSET IN BOTH X AND Y. THE CAUSE IS THAT A LOGIC ERROR WAS FOUND WITHIN THE TUMOR LOC CODEBASE, WHICH RESULTED IN TUMOR LOC BLOCKING ABSOLUTE MARKING FUNCTIONALITY FAILURE WHEN THERE WAS A RECON OFFSET IN EITHER X OR Y, BUT THE BLOCKING ABSOLUTE MARKING FUNCTIONALITY WORKED AS DESIGNED WHEN A RECON OFFSET IN BOTH X AND Y. THE INTENT OF BLOCKING ABSOLUTE MARKING FUNCTIONALITY WAS TO BLOCK ABSOLUTE MARKING WHEN A RECON OFFSET WAS PRESENT. THE CODE THAT COMPUTES ABSOLUTE MARKING COORDINATES DID NOT ACCOUNT FOR THE OFFSET IN EITHER X OR Y, BUT ONLY FOR THE OFFSET IN BOTH X AND Y, PRODUCING INCORRECT COORDINATES. THE SYSTEM WAS NOT IN CLINICAL USE WHEN THIS OCCURRED. A REVIEW OF THE RISK MANAGEMENT FILE INDICATES THE PROBLEM REPORTED BY THE CUSTOMER IS A LOW POTENTIAL SEVERITY WHICH WOULD NOT REASONABLY CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE PROBLEM WERE TO REOCCUR. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME.
THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. IT WAS REPORTED THAT DURING THE PHILIPS INTERNAL TESTING PROCESS, IT WAS FOUND THAT THE CT SERIES RECONSTRUCTED WITH A X OR Y RECONSTRUCTION OFFSET PER DICOM PRIVATE TAG (01F1,100C), WHICH CAN BE USED WITHIN TUMOR LOC TO TRANSMIT INVALID ABSOLUTE MARKING COORDINATES TO A LASER MARKING SYSTEM. THESE INVALID COORDINATES MIGHT RESULT IN AN INCORRECT TREATMENT LOCATION ON THE PATIENT¿S SKIN. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS STARTED THE INVESTIGATION OF THIS EVENT.
THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. IT WAS REPORTED THAT DURING THE PHILIPS INTERNAL TESTING PROCESS, IT WAS FOUND THAT THE CT SERIES RECONSTRUCTED WITH A X OR Y RECONSTRUCTION OFFSET PER DICOM PRIVATE TAG (01F1,100C), WHICH CAN BE USED WITHIN TUMOR LOC TO TRANSMIT INVALID ABSOLUTE MARKING COORDINATES TO A LASER MARKING SYSTEM. THESE INVALID COORDINATES MIGHT RESULT IN AN INCORRECT TREATMENT LOCATION ON THE PATIENT¿S SKIN. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS NOW COMPLETED THE INVESTIGATION OF THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1016535 | BRILLIANCE | COMPUTED TOMOGRAPHY X-RAY SYSTEM | JAK | PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD. | BIG BORE RT | 00884838095168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |