MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-01 for HI-LO TREATMENT TABLE HL3E * manufactured by Dynatronics Corporation.
[18169592]
Patient requested to lay on a hi-lo treatment table. The surface of this table is divided into three equal sections. The head and foot sections can adjust so they can be raised up or dropped down. While the patient was in the process of laying down on the table, the head section which was initially raised up to 45 degrees, dropped down 45 degrees. Patient was assisted back up to sitting position on the edge of the table. After a few minutes, patient complained of increased right lower back pain. Ice and an early end to the treatment session were offered, but patient wished to finish her session. Patient indicated she would ice back at home. The table was brought to maintenance for evaluation. Maintenance was unable to duplicate the incident, but did discover that the shock for the head section required replacement. Head shock, handle and cushion bolts were replaced. Operation tests okay and table placed back in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 679904 |
| MDR Report Key | 679904 |
| Date Received | 2006-02-01 |
| Date of Report | 2006-01-31 |
| Date of Event | 2005-12-27 |
| Report Date | 2006-01-31 |
| Date Reported to FDA | 2006-02-01 |
| Date Added to Maude | 2006-03-01 |
| 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 | HI-LO TREATMENT TABLE |
| Generic Name | TREATMENT TABLE, PHYSICAL THERAPY |
| Product Code | JFB |
| Date Received | 2006-02-01 |
| Model Number | HL3E |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 669180 |
| Manufacturer | DYNATRONICS CORPORATION |
| Manufacturer Address | 7030 PARK CENTER DRIVE SALT LAKE CITY UT 84121 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-02-01 |