MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-15 for TRANSMOTION MEDICAL, INC TMM5-XTB manufactured by Transmotion Medical Inc..
[3394677]
No injury reported. Submitting based on potential. (b)(6) of (b)(6) (surgery center) e-mailed tmm's sales rep stating that they were getting ready for an eye case, and the "tower" (column) started moving on its own. Her concern was that it could have been a safety issue had it occurred during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[10672189]
The remedial action was to replace the pendant, which had been damaged due to an unk cause. The e-mail that was sent to tmm stated they also had an issue with the pendants dragging on the ground, which would not have helped. Transmotion medical, inc is designing a new pendant to launch to improve overall durability/quality and to protect the internal printed circuit board/electronics. This solution is currently undergoing etl testing and will be in place in 2013 for production and service components.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2013-00002 |
| MDR Report Key | 3050539 |
| Report Source | 06 |
| Date Received | 2013-03-15 |
| Date of Report | 2013-03-13 |
| Date of Event | 2013-02-14 |
| Date Mfgr Received | 2013-02-13 |
| Date Added to Maude | 2013-05-20 |
| 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 |
| Remedial Action | RP |
| 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 | 2013-03-15 |
| Model Number | TMM5-XTB |
| Catalog Number | TMM5-XTB |
| Lot Number | 4718 |
| 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 | 2013-03-15 |