MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2002-06-03 for ERGOSTYLE ERGOSTYLE ELEVATION 8760 manufactured by Chattanooga Group A Division Of Encore Medical L.p..
[231210]
Lifting motor over extended causing the treatment table to fall. No consequences to patient.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1022819-2002-00001 |
MDR Report Key | 397748 |
Report Source | 08 |
Date Received | 2002-06-03 |
Date of Report | 2002-06-03 |
Date Mfgr Received | 1999-08-26 |
Device Manufacturer Date | 1997-10-01 |
Date Added to Maude | 2002-06-06 |
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 | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
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 | 4238707218 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Removal Correction Number | 1180 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ERGOSTYLE |
Generic Name | CHIROPRACTIC TREATMENT TABLE |
Product Code | JFB |
Date Received | 2002-06-03 |
Model Number | ERGOSTYLE ELEVATION |
Catalog Number | 8760 |
Lot Number | * |
ID Number | CORRECTIVE ACTION #1180 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 386795 |
Manufacturer | CHATTANOOGA GROUP A DIVISION OF ENCORE MEDICAL L.P. |
Manufacturer Address | 4717 ADAMS RD. HIXSON TN 37343 US |
Baseline Brand Name | ERGOSTYLE |
Baseline Generic Name | CHIROPRACTIC TREATMENT TABLE |
Baseline Model No | ERGOSTYLE ELEVA |
Baseline Catalog No | 8760 |
Baseline ID | CORRECTIVE ACTI |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2002-06-03 |