MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-03-12 for ELECTRIC HI-LO TREATMENT TABLE 6015E manufactured by Midland Mfg Co. / Patterson Medical.
[1486870]
Child had his head caught under treatment table and was standing on the down mechanism, injuring his head. The mother, who was the pt, 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 table, and continued to stand on the down device. Up button was 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
| Report Number | 1634980 |
| MDR Report Key | 1634980 |
| Report Source | 99 |
| Date Received | 2010-03-12 |
| Date of Report | 2010-03-11 |
| Date of Event | 2010-02-25 |
| Date Facility Aware | 2010-02-25 |
| Report Date | 2010-03-11 |
| Date Reported to FDA | 2010-03-11 |
| Date Reported to Mfgr | 2010-03-11 |
| Date Added to Maude | 2010-03-19 |
| 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 | 3 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTRIC HI-LO TREATMENT TABLE |
| Generic Name | ELECTRIC HI-LO TREATMENT TABLE |
| Product Code | INQ |
| Date Received | 2010-03-12 |
| Model Number | 6015E |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 13 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDLAND MFG CO. / PATTERSON MEDICAL |
| Manufacturer Address | BOLINGBROOK IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-03-12 |