MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-05-01 for SUSPENSION TYPE 6 11618A NA manufactured by General Electric Co..
[59704]
The gas spring lost pressure and allowed the x-ray tube and collimator to move rapidly downward. Evidently no one was injured by the event. The failed spring had only been in service for two months. The gas spring has been replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 57331-1997-00015 |
| MDR Report Key | 89286 |
| Report Source | 06 |
| Date Received | 1997-05-01 |
| Date of Report | 1997-05-01 |
| Date of Event | 1997-04-10 |
| Date Mfgr Received | 1997-04-24 |
| Date Added to Maude | 1997-05-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUSPENSION TYPE 6 |
| Generic Name | DIAGNOSTIC X-RAY |
| Product Code | ITY |
| Date Received | 1997-05-01 |
| Model Number | 11618A |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 88268 |
| Manufacturer | GENERAL ELECTRIC CO. |
| Manufacturer Address | 283 RUE DE LA MINIERE, BP 34 78533 BUE CEDEX, FRANCE FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-01 |