MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-24 for COLLIMATOR * manufactured by Siemens Medical Systems, Inc..
[17424324]
The radiographer was moving the x-ray collimator into place to perform a study when the collimator fell from the tube support, narrowly missing a pt. When the svc rep arrived on 10/8/96, it appeared that the threads holding the screws for the collimator were stripped out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010148 |
| MDR Report Key | 44570 |
| Date Received | 1996-10-24 |
| Date of Report | 1996-10-11 |
| Date of Event | 1996-10-05 |
| Date Added to Maude | 1996-10-28 |
| 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 |
| 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 | COLLIMATOR |
| Generic Name | COLLIMATOR |
| Product Code | KPW |
| Date Received | 1996-10-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 45489 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 186 WOOD AVE SOUTH ISELIN NJ 08830 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-10-24 |