MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-01-02 for TRE-DH3 7286 manufactured by Chattanooga Group.
[2687991]
The treating clinician was setting on a rolling therapy stool and inadvertently bumped into the therapy treatment table platform release lever in an unsafe manner. The inadvertent bump of the lever caused sudden movement in the treatment table platform supporting the upper part of the pt. The pt's neck hyperextended from the sudden movement and result in the necessity for professional medical intervention. Extent or type of intervention is unk.
Patient Sequence No: 1, Text Type: D, B5
[9962626]
Unit was not returned for eval. Per complainant description, inadvertent activation by physician led to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00390 |
| MDR Report Key | 2555798 |
| Report Source | 06 |
| Date Received | 2009-01-02 |
| Date of Report | 2007-11-05 |
| Date Mfgr Received | 2007-11-05 |
| Date Added to Maude | 2012-05-03 |
| 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 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 | TRE-DH3 |
| Generic Name | PHYSICAL THERAPY TREATMENT TABLE |
| Product Code | INQ |
| Date Received | 2009-01-02 |
| Model Number | 7286 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 4717 ADAMS RD. HIXSON TN 37343 US 37343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-02 |