FDA Adverse Event
Other
Summary report: N
COHERENCE DOSIMETRIST + ONCOLOIGST WORKSPORE
MDR report key: 618860
·
Received August 3, 2004
Report
- Report Number
- 2910081-2004-00001
- Event Type
- Other
- Date Received
- August 3, 2004
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- HJW
- Removal / Correction Number
- 2910081-08/04/04-005C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AN EVENT DID NOT OCCUR, HOWEVER AN INTERMITTENT SOFTWARE ANOMALY HAS BEEN DISCOVERED WHEREBY IMPORTED DATA MAY BE MISSING AFTER PERFORMING A DICOM EXPORT. THE MISSING DATA MAY CAUSE INCORRECT TREATMENT PLANNING FOR RADIATION THERAPY ON THIRD PARTY VENDOR SOFTWARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COHERENCE DOSIMETRIST + ONCOLOIGST WORKSPORE | SW OPTION FOR MEDICAL CHARGED-PARTICLE RADIATION THERAPY | HJW | SIEMENS MEDICAL SOLUTIONS USA, INC. | 5856641 7333680 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |