MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-29 for SRO 33/100 X-RAY TUBE ASSEMBLY 9874-005-16022 NA manufactured by Philips Medezin Systeme.
[222552]
Reportedly, while the pt was undergoing a tomographic procedure of the spine (lumbar-sacral), the x-ray tube heat integrator on the x-ray generator of the tomographic system indicated that the x-ray tube was too hot. The technologist turned off x-rays for approx 15 minutes to allow the x-ray tube to cool. After cooling, the procedure was restarted and during this time, it is alleged that the pt stated that some liquid was falling on the pt. It was found that oil from the x-ray tube housing assembly had dripped on the pt's right thigh. The pt was examined in er, and per the examining physician, there was no evidence of any injury (burns, blistering or rash) to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 340870 |
| MDR Report Key | 340870 |
| Date Received | 2001-06-29 |
| Date of Report | 2001-04-11 |
| Date of Event | 2001-04-05 |
| Date Facility Aware | 2001-04-09 |
| Report Date | 2001-04-11 |
| Date Reported to Mfgr | 2001-04-27 |
| Date Added to Maude | 2001-07-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SRO 33/100 X-RAY TUBE ASSEMBLY |
| Generic Name | DIAGNOSTIC X-RAY TUBE HOUSING ASSEMBLY |
| Product Code | ITY |
| Date Received | 2001-06-29 |
| Model Number | 9874-005-16022 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6.5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 330193 |
| Manufacturer | PHILIPS MEDEZIN SYSTEME |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-06-29 |