MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-03-07 for DAYTONA TABLE; TAVO-VL4 manufactured by Consultronix S.a..
[4392738]
A distributor reported that when the button was pushed, the table was able to move below the zero point when descending on the column. There was no report of a patient being involved in event, nor was there any report of a patient injury.
Patient Sequence No: 1, Text Type: D, B5
[11799082]
A distributor reported that the device continued to descend past the zero position when the button was pushed. The table did not move spontaneously, but could be forced below the zero point when the button was pushed. Under ordinary operation, once the table reached the zero position on the column, the table should not respond to pushing the button to descend. The worst case scenario for risk is where the user continues to force the table to descend, which could eventually sever the electrical cable / damage the electrical plug. If the cable is severed, there is a risk of a shock being delivered to the patient or user from the exposed cable. The company's investigation concluded that this condition could occur under the following circumstances which would make the possibility of serious injury extremely remote: a greater than 15% drop in voltage delivered to the unit; the user pushes the button to drive the unit below the zero point; the user does not notice that the table continues to descend past the zero point; and the user delivers enough force (in a single instance or over time) to sever the cable or damage the plug (approximately 3400n) (note that the column's maximum downward force is 2500n). While the company has not had a report of shock associated with this failure mode and believes the potential for injury is highly unlikely, the company is submitting this report out of an abundance of caution. Consultronix is issuing a field notification to inform customers of this issue and an aluminum block that will provide a mechanical stop to prohibit the descent of the table past the zero point on the column. The field notification and aluminum block will be sent to all customers in the u. S. With potentially affected product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008478792-2014-00001 |
| MDR Report Key | 3831961 |
| Report Source | 08 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-03-07 |
| Date of Event | 2014-02-07 |
| Date Mfgr Received | 2014-02-10 |
| Device Manufacturer Date | 2013-06-11 |
| Date Added to Maude | 2014-06-13 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | UL. RACLAWICKA 58 |
| Manufacturer City | KRAKOW 30-017 |
| Manufacturer Country | PL |
| Manufacturer Postal | 30-017 |
| Manufacturer Phone | 8122902222 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | 3008478792-3/7/2014-001- |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAYTONA TABLE; TAVO-VL4 |
| Generic Name | TABLE, INSTRUMENT, POWERED, OPHTHALM |
| Product Code | HRJ |
| Date Received | 2014-03-07 |
| Model Number | TAVO-VL4 |
| Catalog Number | TAVO-VL4 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSULTRONIX S.A. |
| Manufacturer Address | KRAKOW PL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-07 |