MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-13 for TRANSMOTION MEDICAL, INC. TMM4-XWTB manufactured by Transmotion Medical Inc..
[3044751]
Very little information was known about this specific event as multiple contacts were made at the facility around the original occurrence of this incident, and little information was shared at that time. Patient moved up toward the head of the chair, and it started to tip over. The chair was "caught" by two caregivers and moved the patient back down to the seat section. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[10317673]
Specific serial number unknown by the facility. A general view of all the devices found that nothing at all was found to be deficient with them. Multiple follow-ups were made by our sales representative at the time and little more information was received. Not much else was required as the patient's weight was moved too far up the back section and the warning labels weren't adhered to.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2012-00007 |
| MDR Report Key | 2845007 |
| Report Source | 06 |
| Date Received | 2012-11-13 |
| Date of Report | 2012-11-12 |
| Date of Event | 2009-08-07 |
| Date Mfgr Received | 2009-08-07 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2012-12-07 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSMOTION MEDICAL, INC. |
| Generic Name | TMM5 MOBILE SURGICAL STRETCHER-CHAIR |
| Product Code | GBB |
| Date Received | 2012-11-13 |
| Model Number | TMM4-XWTB |
| Catalog Number | TMM4-XWTB |
| Lot Number | 1822-1833 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2012-11-13 |