MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-06 for ZEE TS-1 72-2804-1 manufactured by Marco Opthalmic. Inc..
[41416]
Table top was becoming increasingly difficult to move longitudinally. A long scrape was evident just under the table top that paralleled the table range of travel. Table supports a vision tester, auto-refractometer and a non-contact keratometer. Inspection found the table top rail roller surface had bent from a 90 degree angle to about 120 degree. The difficulty in table top travel and the scrape were a result of the bent rail. With the rail removed, a three foot groove was worn longitudinally inside the aluminum rail. Most of the equipment weight was distributed towards the pt's side of the table. This imbalance put constant upward pressure on two steel rollers on which the rail traversed, one of which over time wore the groove into the rail. The rail wore to the point that it eventually began to bend. If not identified in time there is a potential for the table top to tip over, dumping the equipment to the ground or worse into a pt's lap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001795 |
| MDR Report Key | 74123 |
| Date Received | 1997-03-06 |
| Date of Report | 1996-03-27 |
| Date Added to Maude | 1997-03-10 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZEE |
| Generic Name | OPHTHALMIC TRANSLATING TABLE |
| Product Code | HRJ |
| Date Received | 1997-03-06 |
| Model Number | TS-1 |
| Catalog Number | 72-2804-1 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 73953 |
| Manufacturer | MARCO OPTHALMIC. INC. |
| Manufacturer Address | 11825 CENTRAL PKWY JACKSONVILLE FL 32224 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-06 |