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 |