MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-05-21 for EUREKA LINEAR IIIP 93741 (PICKER MODEL NO.) 70-53000P (PROGENY MODEL NO.) manufactured by Progeny, Inc..
[135172]
The collimator disconnected from the x-ray tube assembly. The collimator is attached to the x-ray tube by a collar that locks with a hinged locking mechanism. The collar has a safety catch that is attached by a cap screw at the time of installation. The threads of the screw have vibratite, a reusable thread locking product, applied to prevent the screw from backing out due to vibration. The product is shipped with a red warning notice instructing the installer to read the installation instructions. These instructions describe the proper installation of the safety catch and to only use the screw provided that has vibratite. Co's conclusion is that installer either did not install the safety catch properly or used their own screw that did not have vibratite.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423380-1998-00001 |
| MDR Report Key | 168953 |
| Report Source | 00 |
| Date Received | 1998-05-21 |
| Date of Report | 1998-05-13 |
| Date of Event | 1998-04-01 |
| Date Mfgr Received | 1998-05-06 |
| Device Manufacturer Date | 1997-04-01 |
| Date Added to Maude | 1998-05-28 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EUREKA LINEAR IIIP |
| Generic Name | COLLIMATOR |
| Product Code | IZX |
| Date Received | 1998-05-21 |
| Model Number | 93741 (PICKER MODEL NO.) |
| Catalog Number | 70-53000P (PROGENY MODEL NO.) |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 160076 |
| Manufacturer | PROGENY, INC. |
| Manufacturer Address | 600 WEST UNIVERSITY DR. ARLINGTON HEIGHTS IL 60004 US |
| Baseline Brand Name | EUREKA LINEAR IIIP |
| Baseline Generic Name | COLLIMATOR |
| Baseline Model No | 93741 (PICKER M |
| Baseline Catalog No | 70-53000P (PROGENY MODEL NO.) |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-21 |