MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-07 for TRACTION UNIT, POWERED, MOBILE TX-1 manufactured by Chattanooga Corp..
[11421]
Pt presented for outpatient cervical traction treatment. Had used same machine several times before as an inpatient. Pt was given call light and kill switch for machine. Treatment began at 20 lbs, was gradually increased to 25 lbs. Approx 5 mins after traction increase the pt called out and stopped the machine. He complained that the pull had increased and pulled the halter and head rest off of his head and neck. He denied any pain or dizziness immediately and the treatment was discontinued. The machine was taken out of svc and checked by the clinical engineering dept.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 20694 |
| MDR Report Key | 20694 |
| Date Received | 1995-03-07 |
| Date of Report | 1995-03-06 |
| Date of Event | 1995-01-18 |
| Date Facility Aware | 1995-02-28 |
| Report Date | 1995-03-06 |
| Date Added to Maude | 1995-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACTION UNIT, POWERED, MOBILE |
| Generic Name | TRACTION UNIT, POWERED, MOBILE |
| Product Code | ITH |
| Date Received | 1995-03-07 |
| Model Number | TX-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 13 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 20578 |
| Manufacturer | CHATTANOOGA CORP. |
| Manufacturer Address | HIXSON TN 373430489 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-03-07 |