MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-07-24 for TOSHIBA DFP-8000D manufactured by Toshiba Medical System Corp.
[914575]
In 2008, it was reported that a patient allegedly experienced a radiation burn. It was found that the patient was exposed for approximately 160 minutes.
Patient Sequence No: 1, Text Type: D, B5
[7885390]
A fluoroscopic performance evaluation was conducted by a physicist per the administrative code (tac) regulations as well as additional image quality standards (e. G. , radiation safety, image quality, etc. ) the system was evaluated in 2008, and again three months later, just after this incident was reported. There were no problems noted and the system passed all requirements. Error log data and study information from the data base have been obtained from site for investigation into the cause of this incident. A review of this information did not reveal a system problem, but did reveal that the study exposure time was approximately 160 minutes as reported. Toshiba does not believe further actions are required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020563-2008-00002 |
| MDR Report Key | 1084725 |
| Report Source | 05,06,07 |
| Date Received | 2008-07-24 |
| Date of Report | 2008-07-08 |
| Date of Event | 2008-04-23 |
| Date Mfgr Received | 2008-07-11 |
| Date Added to Maude | 2008-08-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAUL BIGGINS |
| Manufacturer Street | 2441 MICHELLE DRIVE |
| Manufacturer City | TUSTIN CA 92780 |
| Manufacturer Country | US |
| Manufacturer Postal | 92780 |
| Manufacturer Phone | 7147305000 |
| Manufacturer G1 | TOSHIBA MEDICAL SYSTEMS CORP |
| Manufacturer Street | 1385 SIMOISHIGAMA OTAWARA-SHI |
| Manufacturer City | TOCHIGI 324-8550 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 324-8550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSHIBA |
| Generic Name | X-RAY, DIGITAL FLUOROGRAPHY |
| Product Code | IZG |
| Date Received | 2008-07-24 |
| Model Number | DFP-8000D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1057997 |
| Manufacturer | TOSHIBA MEDICAL SYSTEM CORP |
| Manufacturer Address | 1385 SHIMOISHIGAMI, OTAWARA-SHI TOCHIGI JA 324-8550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-24 |