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 TX-1 POWER TRACTION DEVICE 7240 manufactured by Chattanooga Group.
[17017783]
A pt was injured during traction therapy and treatment was stopped. After the event, a tech was sent and determined that the unit was out of calibration by 20-22%. He recalibrated the unit. The pt returned to the p. T. Office in 2006 inflamed and swollen. She is scheduled for physical therapy about four days later.
Patient Sequence No: 1, Text Type: D, B5
[17242327]
Only control panel (p/n 70217) was returned for evaluation, which indicates that at the time of treatment, the unit was 1. 5 years old. It is not known at this time whether the unit was calibrated after 1 year of service or had undergone any preventative maintenance. Calibration was checked: 20 lbs= 22 lbs, 100 lbs= 108 lbs, 200 lbs= 214 lbs. Unit was not properly calibrated by field technician. Meter would only go up to 198 lbs max. , zero was flashing -01. Conclusion: control board was removed from unit and recalibrated. It is impossible to determine the state of calibration at the time of removal from unit. The calibration done by the field technician was not correct. Unit calibrated properly and returned to stock.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00330 |
| MDR Report Key | 1280492 |
| Report Source | 06 |
| Date Received | 2009-01-02 |
| Date of Report | 2006-09-25 |
| Date of Event | 2006-09-25 |
| Date Mfgr Received | 2006-09-25 |
| Date Added to Maude | 2009-02-06 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS ROAD |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238707207 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TX-1 POWER TRACTION DEVICE |
| Product Code | ITH |
| Date Received | 2009-01-02 |
| Returned To Mfg | 2006-10-26 |
| Model Number | 7240 |
| 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 ROAD HIXSON TN 37343 US 37343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-02 |