MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 0000-00-00 for MIDLAND ELECTRIC HI-LO TREATMENT TABLE 6015E manufactured by Midland Manufacturing.
[19935671]
Device was evaluated by third party forensic testing company. Unit was fully functional and did not show any evidence of device failure. Controls on the device are standard for this type of product. Model design was tested by underwriters laboratory for safety issues through ul 544 and passed. Findings: the table is a midland mfg co physical therapy table model 6015e, (b) (4). Parts of the table surface can be repositioned by hand to accommodate the positioning needs of the pt. The table surface can be raised and lowered by an electric motor to allow easy pt and therapist access; only the table's height is power adjustable. The motor is activated by a pneumatic footswitch. The footswitch has a down side and up side as indicated by labeling on the footswitch surface. The footswitch was reportedly installed by (b) (6) to replace the table's original hand switch. The table appears in good condition with only a damaged and a missing locking screw, one on each arm rest. The table is wheeled and has brakes on each wheel that, when applied, hold the table in place. The table surface does move up and down in response to force on the footswitch. When sufficient force is applied to the switch, the table surface moves in the chosen direction and stops when the force is released. The table does not appear to have any defects that would affect its normal and expected operation.
Patient Sequence No: 1, Text Type: N, H10
[20027945]
Child had his head caught under treatment table while standing on down switch, injuring his head. Mother of the child was lying on the treatment table and her son had been sitting on her stomach. Staff member had gone to the other end of the room to put hot packs away, when she heard mother calling for help. Mother said that her son was lowering her on the table and bent down to look and got his head caught under the table and continued to stand on the down switch for the table. Up button was then pushed to release child and medical team arrived. Child was treated at the scene and transported to the hospital where he later died.
Patient Sequence No: 1, Text Type: D, B5
| Brand Name | MIDLAND ELECTRIC HI-LO TREATMENT TABLE |
| Generic Name | ELECTRIC HI LO TREATMENT TABLE |
| Product Code | INQ |
| Model Number | 6015E |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDLAND MANUFACTURING |
| Manufacturer Address | 802 UNIVERSAL DR. COLUMBIA SC 29209 US 29209 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 0000-00-00 |