MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-20 for PRISM 2000 manufactured by Picker International, Inc..
[20886282]
While in use, scanning a pt, unit will lock up. Camera head would not lock in position & moved downward, pinning pt's head to the exam table. Without timely intervention, serious injury was possible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000714 |
| MDR Report Key | 25853 |
| Date Received | 1995-07-20 |
| Date of Report | 1995-03-03 |
| Date Added to Maude | 1995-09-22 |
| 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 | PHYSICIST |
| 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 | PRISM |
| Generic Name | GAMMA SCANNING CAMERA |
| Product Code | IXY |
| Date Received | 1995-07-20 |
| Model Number | 2000 |
| ID Number | 1524110 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 26496 |
| Manufacturer | PICKER INTERNATIONAL, INC. |
| Manufacturer Address | 7014 FAIRFIELD BUSINESS FAIRFIELD OH 45014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-20 |