MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-02 for FORTE' PEGASYS manufactured by Philips Medical Systems.
[17490474]
Collimator in/out did not function correctly on the hand control. While pressing and holding either enable button and then pressing in or out the motion would not occur until you released the in or out button. The motion selected then occurs after release of in or out button and will stop only when the enable is released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004871 |
| MDR Report Key | 975305 |
| Date Received | 2008-01-02 |
| Date of Report | 2008-01-02 |
| Date of Event | 2007-12-10 |
| Date Added to Maude | 2008-01-14 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORTE' PEGASYS |
| Generic Name | NUCLEAR MEDICINE GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2008-01-02 |
| Model Number | FORTE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 945089 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 22100 BOTHELL EVERETT HIGHWAY PO BOX 3003 BOTHELL WA 980413003 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-02 |