MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-13 for EDEC 80 X-RAY MACHINE AND CGR * manufactured by Unk.
[16288649]
Repair to collimator as surggested by radiation protection. Medical imaging svc tech repaired collimator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 35491 |
| MDR Report Key | 35491 |
| Date Received | 1996-07-13 |
| Date of Report | 1996-07-12 |
| Date Added to Maude | 1996-08-20 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDEC 80 X-RAY MACHINE AND CGR |
| Generic Name | X-RAY MACHINE AND SPOT FILM DEVICE |
| Product Code | ITY |
| Date Received | 1996-07-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 123020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 36908 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-07-13 |