MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-07 for LIEBEL FLARSHEIM LINEAR IV 7075500FR manufactured by Eureka X-ray Tube Co..
[18552985]
During cysto ureteroscopy stent placement staff noted a burning smell coming from the collimator with black smoke coming out the vents. Measures were taken to protect the pt and the machine was cut off. "pnc" for evenings was notified, x-ray supervisor was notified. It was noted that the housing of the collimator is melted and discolored. Tuesday morning the co was notified of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014353 |
| MDR Report Key | 181355 |
| Date Received | 1998-08-07 |
| Date of Report | 1998-08-06 |
| Date of Event | 1998-08-03 |
| Date Added to Maude | 1998-08-11 |
| 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 | LIEBEL FLARSHEIM |
| Generic Name | LINEAR X-RAY COLLIMATOR |
| Product Code | ITY |
| Date Received | 1998-08-07 |
| Model Number | LINEAR IV |
| Catalog Number | 7075500FR |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 176348 |
| Manufacturer | EUREKA X-RAY TUBE CO. |
| Manufacturer Address | 600 WEST UNIVERSITY DRIVE ARLINGTON HEIGHTS IL 60004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-08-07 |