MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-22 for ERGOSTYLE FX 5820 manufactured by .
[1262009]
On the 24th of june a female pt (b)(6) was at her chiropractor for the treatment of back pain. When attempting to position herself on the table she placed her hand on the pelvic section for support and the pelvic section pivoted causing the pt to fall to the ground hitting her elbow. Per the attending healthcare professional the pt's progress toward recovery was not impeded and medical treatment for the fall was not required.
Patient Sequence No: 1, Text Type: D, B5
[8370483]
Repair of the table found the mechlok on the pelvic section had locked-up and the limit switch associated with the pelvic tilt was broken. This complaint was reported twice. The first complaint involved the incident and the second complaint stated only that the pelvic section was locked-up. The table was received by our service dept on the second complaint, repaired and returned to the customer. After repair full functional tests were performed and the table was inspected by a quality engineer before returning the table to the customer. A six month review of complaints for this table was evaluated. Ten of the complaints involved failure of the mechlok. The mechlok is expected to fail with excessive use and the failure rate, based on the # of complaints is approximately 55 per million treatments. This unique incident, is of low severity with a potential for approximately 3 incidents per million treatments. Per the instructions for use the occurrence could be mitigated if the warnings, cautions and dangers are followed. The table should be locked before the loading or unloading of a pt and the cables and connectors should be inspected prior to use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00165 |
| MDR Report Key | 1481982 |
| Report Source | 05 |
| Date Received | 2009-07-22 |
| Date of Report | 2009-06-25 |
| Date of Event | 2009-06-24 |
| Date Mfgr Received | 2009-06-25 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2010-06-08 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERGOSTYLE FX |
| Product Code | INQ |
| Date Received | 2009-07-22 |
| Returned To Mfg | 2009-07-13 |
| Model Number | 5820 |
| Catalog Number | 5820 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-22 |