MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-11-20 for TRANSMOTION MEDICAL, INC. TMM5-TB manufactured by Transmotion Medical, Inc..
[5227156]
There was no pt event therefore, we are leaving the date above as "n/a". A service call was received on 09/18/2014 to address the product moving on its own. It was decided on 10/21/2014, that we should launch an mdr as good measure for reporting purposes. This mdr is being filed to notify of the potential for injury due to the chair moving on its own due to a design issue with the hand control pendant. Again, there was no pt nor a pt incident involved.
Patient Sequence No: 1, Text Type: D, B5
[12584187]
The immediate action taken was to replace all older styler pendants with newly designed pendants for all devices in the facility. There was not an adverse event. No pt was on the device. Transmotion medical inc. Has designed a new pendant which was released in may of 2013. The new pendant is considerably more durable than the older style pendants. The new pendant has been in production for 17 months and there have been no reports of the new pendant causing the device to move on its own. Additionally, in november 2014, transmotion medical, inc launched a product recall due to previous customer complaint and corresponding mdr data.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2014-00002 |
| MDR Report Key | 4286539 |
| Report Source | 06 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-11-14 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2014-12-04 |
| 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 | RL |
| 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 | 2014-11-20 |
| Model Number | TMM5-TB |
| Catalog Number | TMM5-TB |
| Lot Number | 1338, 1355-1362 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2014-11-20 |