MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-23 for PROGENCY, INC 93741 * manufactured by Progeny, Inc..
[85603]
While positioning the collimator and shutter device, collimator and shutter device disconnected from the x-ray tube assembly. The collimator and shutter device dropped onto the pt's hip area. Pt rec'd bruising to the hip. Svc co was contacted to inspect and repair the unit. Upon inspection it was found the a screw was loose on the band which secures the collimator and shutter device to the x-ray tube assembly. This loose screw allowed the safety catch to release which resulted in the above mentioned incident. The band had been replaced in december 1997 or january 1998. This band was not the band originally installed on the equipment. Co advised that the band appeared to have a design defect. To prevent future occurrences, the screw on these devices will have "lock tight" place on the screw. A schedule for biomedical engineering to inspect the device has been implemented. This will augment the inspections done by the svc rep. Daily checks of the device will be done by the technicians in radiological svcs. Problems will be reported and checks documented.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013630 |
| MDR Report Key | 164459 |
| Date Received | 1998-04-23 |
| Date of Report | 1998-04-10 |
| Date of Event | 1998-04-01 |
| Date Added to Maude | 1998-04-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | PROGENCY, INC |
| Generic Name | COLLIMATOR & SHUTTER DEVICE |
| Product Code | IZX |
| Date Received | 1998-04-23 |
| Model Number | 93741 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 160076 |
| Manufacturer | PROGENY, INC. |
| Manufacturer Address | 600 W. UNIVERSITY DR. SUITE A ARLINGTON HGHTS. 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 | 1998-04-23 |