MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-05 for TRACTION MACHINE - ME 4000 manufactured by Mettler Electronics Corp.
[3448524]
A pt was placed into a harness for cervical traction. The cable was pretested for slipping by pt. The cable was attached to the harness by the pt. As the cable was attached, there was no noted abnormality or fraying of the cable. The traction pull was initiated. When the pull reached about 17 lbs on the digital readout, the cable broke from the clip. The traction harness was disengaged from the motor suddenly. 140291-2013-8.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030472 |
| MDR Report Key | 3161615 |
| Date Received | 2013-06-05 |
| Date of Report | 2013-05-20 |
| Date of Event | 2013-05-17 |
| Date Added to Maude | 2013-06-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACTION MACHINE - ME 4000 |
| Generic Name | MTD - ME 4000 |
| Product Code | ITH |
| Date Received | 2013-06-05 |
| Model Number | ME 4000 |
| ID Number | ACE CONTROL# 03010362 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METTLER ELECTRONICS CORP |
| Manufacturer Address | 1333 SOUTH CLAUDINA ST ANAHEIM CA 92805 US 92805 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-05 |