MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-12-23 for FF450 POWER TABLE IT -3F NA manufactured by Carl Zeiss Meditec Ag.
[18162630]
The complainantt reported that during patient testing, the rocker switch was pushed to lower the table and the table kept going down when the switch was released. There was no reported injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[18359862]
The table in question is being returned for evaluation. As of the submission of this report, the table has not been received for evaluation. A separate follow-up will be submitted once the table is evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615030-2004-00002 |
| MDR Report Key | 786059 |
| Report Source | 05,06 |
| Date Received | 2004-12-23 |
| Date of Report | 2004-12-23 |
| Date of Event | 2004-12-01 |
| Date Mfgr Received | 2004-12-01 |
| Date Added to Maude | 2006-11-27 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 5160 HACIENDA DR |
| Manufacturer City | DUBLIN CO 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574353 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG |
| Manufacturer Street | GOSCHWITZER STR 51-52 |
| Manufacturer City | JENA 07745 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 07745 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FF450 POWER TABLE |
| Generic Name | INSTRUMENT TABLE |
| Product Code | INQ |
| Date Received | 2004-12-23 |
| Model Number | IT -3F |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 773858 |
| Manufacturer | CARL ZEISS MEDITEC AG |
| Manufacturer Address | * JENA GM |
| Baseline Brand Name | FF450 POWER TABLE |
| Baseline Generic Name | INSTRUMENT TABLE |
| Baseline Model No | IT -3F |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-23 |