MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-13 for OLYMPUS TC-V1 56419 manufactured by Olympus Optical Co., Ltd..
[9346]
On two seperate occasions, the tc-v1 cart fell over during transport. In each case, the cart was being transported with th emonitor on the top shelf even though it states in our labeling that the monitor shouild be removed while being transported. During one incident, the rn sustained bruises to her leg but in th esecond incident, there wasn't any occurrence of personal injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429304-1994-00045 |
| MDR Report Key | 13544 |
| Date Received | 1994-04-13 |
| Date of Report | 1994-03-31 |
| Date Facility Aware | 1994-03-21 |
| Report Date | 1994-04-01 |
| Date Reported to FDA | 1994-04-01 |
| Date Reported to Mfgr | 1994-04-01 |
| Date Added to Maude | 1994-05-26 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS TC-V1 |
| Generic Name | VIDEO CART |
| Product Code | HJG |
| Date Received | 1994-04-13 |
| Model Number | TC-V1 |
| Catalog Number | 56419 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13542 |
| Manufacturer | OLYMPUS OPTICAL CO., LTD. |
| Manufacturer Address | SHINJUKU SAN-EI BLDG. 22-2, NISHI SHINJUKU 1-CHROME SHINJUKU, TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-04-13 |