MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-23 for TUBE HOUSING ASSEMBLY DUNLEE PX-13C5 5003566 manufactured by Picker Intl..
[19151360]
During a lumbar spine and pelvic x-ray procedure, the x-ray tube/tube housing of the overhead x-ray tube "exploded". The circular metal cap on one end of the tube housing was blown off the tube with explosive force. The pt and the technologist were showered with hot oil (from tube assembly), which sprayed over 70% of all surfaces within the r&f suite. Both the pt and the technologist were taken to the emergency room at medical ctr and were both discharged with no injury. Equipment has been under service by mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006049 |
| MDR Report Key | 21986 |
| Date Received | 1995-05-23 |
| Date of Report | 1995-05-16 |
| Date of Event | 1995-05-15 |
| Date Added to Maude | 1995-05-30 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUBE HOUSING ASSEMBLY |
| Generic Name | TUBE HOUSING ASSEMBLY |
| Product Code | ITY |
| Date Received | 1995-05-23 |
| Model Number | DUNLEE PX-13C5 |
| Catalog Number | 5003566 |
| Lot Number | 3N30125 |
| ID Number | 1340 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22060 |
| Manufacturer | PICKER INTL. |
| Manufacturer Address | CLEVELAND OH 44143 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-05-23 |