MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-26 for ELEKTA GAMMAKNIFE, AB C manufactured by Elekta, Ab.
[20927920]
Emergency stop was activated (depressed) while gammaknife unit was in treatment positon, during a monthly qa procedure. When emergency stop button was pulled out and reset button depressed, gammaknife failed to move treatment couch out and close the treatment door. No pt was involved. Cause: relay associated with the emergency stop failed to disengage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014534 |
| MDR Report Key | 1589590 |
| Date Received | 2010-01-26 |
| Date of Report | 2010-01-19 |
| Date of Event | 2010-01-15 |
| Date Added to Maude | 2010-02-04 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEKTA GAMMAKNIFE, AB |
| Generic Name | GAMMAKNIFE |
| Product Code | IWB |
| Date Received | 2010-01-26 |
| Model Number | C |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA, AB |
| Manufacturer Address | 475 PEACHTREE INDUSTRIAL BLVD. NORCROSS GA 30092 US 30092 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-26 |