MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-23 for ATP9 TRACTION UNIT manufactured by Huntleigh Akron.
[16148565]
Atp9 unit being used for overhead cervical traction with cord fully extended. Pt interrupt switch activated by pt, machine should have released tension, but due to cord being fully extended, tension was applied. No injury was sustained by pt. Pt was subsequently released by removing from harness, by undoing velcro.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 73654-2001-00001 |
| MDR Report Key | 318936 |
| Date Received | 2001-02-23 |
| Date of Report | 2001-02-14 |
| Date of Event | 2000-11-30 |
| Date Facility Aware | 2001-01-29 |
| Report Date | 2001-02-21 |
| Date Added to Maude | 2001-03-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | ATP9 TRACTION UNIT |
| Generic Name | TRACTION MACHINE |
| Product Code | ITH |
| Date Received | 2001-02-23 |
| Returned To Mfg | 2000-12-01 |
| Model Number | ATP9 |
| Catalog Number | ATP9 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 308481 |
| Manufacturer | HUNTLEIGH AKRON |
| Manufacturer Address | 1, FARTHING RD IPSWICH, SUFFOLK UK IP1 5AP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-02-23 |