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 TRITON DTS 2841 manufactured by Chattanooga Group.
[20238727]
Therapist was providing cervical traction when the rope just released. Therapist mentioned that the unit had a constant humming since the day it was unboxed and placed into service. The humming was constant like that of a pc fan running. As conveyed, the unit was in progress of a cervical traction when the unit appeared to error and released the patient from treatment. The unit did have error 309 twice prior to the event. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[20608924]
The evaluation revealed that the rope had misaligned with the pulley assembly adjacent to the device load cell. Misalignment is typical of product mis-use and/or product mis-handling. The device user manual, as attached, specifically indicates not to mis-use and/or mis-handle product, not to use product if errors appear, and inspect the product prior to each use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00373 |
| MDR Report Key | 1280531 |
| Report Source | 06 |
| Date Received | 2009-01-02 |
| Date of Report | 2007-12-20 |
| Date Mfgr Received | 2007-12-20 |
| Date Added to Maude | 2009-01-12 |
| 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 | TRITON DTS |
| Product Code | ITH |
| Date Received | 2009-01-02 |
| Returned To Mfg | 2008-01-16 |
| Model Number | 2841 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2009-01-02 |