MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-10-24 for TRANSMOTION MEDICAL, INC. TMM3-B 1531 manufactured by Transmotion Medical Inc..
[3031303]
At (b)(6) hospital, the transport department went up to the room to get a stroke pt to transport in the tmm3 chair for her video swallow study procedure. They sat her up she fell through the back of the chair, and it was stated that she "cut her head. "
Patient Sequence No: 1, Text Type: D, B5
[10265570]
Tmm's sales representative went to the facility to review the situation (b)(4) 2012. It was clear the facility didn't use the proper accessory (back rest extension) that is used for transport. The back rest extension was found by the staff in the closet. The staff was retrained on the importance of using the device as it was designed for safe and proper use. There was no deficiencies with the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2012-00003 |
| MDR Report Key | 2823721 |
| Report Source | 99 |
| Date Received | 2012-10-24 |
| Date of Report | 2012-10-23 |
| Date of Event | 2012-09-28 |
| Date Mfgr Received | 2012-10-03 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2012-11-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 1441 WOLF CREEK TRAIL |
| Manufacturer City | SHARON CENTER OH 44274 |
| Manufacturer Country | US |
| Manufacturer Postal | 44274 |
| Manufacturer Phone | 3302394192 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSMOTION MEDICAL, INC. |
| Generic Name | TMM3 VIDEO SWALLOW STUDY CHAIR |
| Product Code | GBB |
| Date Received | 2012-10-24 |
| Model Number | TMM3-B |
| Catalog Number | 1531 |
| Lot Number | 1532 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRANSMOTION MEDICAL INC. |
| Manufacturer Address | 1441 WOLF CREEK TRAIL SHARON CENTER OH 44274 US 44274 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-10-24 |