MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-01-30 for ERGOSTYLE FX WITH MANUAL DROPS 5820 manufactured by Chattanooga Group.
[19958520]
The clinician was lowering the table surface with the patient on the table surface when the motor malfunctioned. The table reached full retraction and the motor continued to attempting to lower the table surface. This action caused the upper yoke where the motor is secured to flex. The flex motion broke the casting of the actuator. The broken piece of casting did eject from under the table.
Patient Sequence No: 1, Text Type: D, B5
[20099810]
Awaiting device return and evaluation. Once the device is returned and evaluated, a concluding form 3500a will be sent to the fda-mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00021 |
| MDR Report Key | 1343363 |
| Report Source | 05 |
| Date Received | 2009-01-30 |
| Date of Report | 2009-01-06 |
| Date Mfgr Received | 2009-01-06 |
| Date Added to Maude | 2009-08-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERGOSTYLE FX WITH MANUAL DROPS |
| Product Code | INW |
| Date Received | 2009-01-30 |
| Returned To Mfg | 2009-01-28 |
| Model Number | 5820 |
| Catalog Number | 5820 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-30 |