MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-10 for TRANSMOTION MEDICAL, INC. TMM5-TB manufactured by Transmotion Medical Inc..
[5629000]
Customer called technical service line and said that the chair moved on its own without pushing any of the buttons on the pendant. Email received from (b)(6) said the chair moved during a procedure but there were no injuries caused at all.
Patient Sequence No: 1, Text Type: D, B5
[12975673]
The immediate action taken was to replace older style pendants with newly designed pendants for all devices in the facility under the current voluntary recall. There was not an adverse event. The customer originally said that the chair moved on its own. Then later in an email, said the chair moved during a procedure "no injuries caused at all. " 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 22 months and there has been one customer claim that the new pendant caused the chair to move on its own but this could not be confirmed. In november 2014, transmotion medical, inc launched a product recall due to previous customer complaint and corresponding mdr data. This mdr is for voluntary reporting purposes only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2015-00001 |
| MDR Report Key | 4600679 |
| Report Source | 05 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-03-10 |
| Date of Event | 2015-02-12 |
| Date Mfgr Received | 2015-02-12 |
| Date Added to Maude | 2015-03-16 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSMOTION MEDICAL, INC. |
| Generic Name | TMM5 SURGICAL STRETCHER-CHAIR |
| Product Code | GBB |
| Date Received | 2015-03-10 |
| Model Number | TMM5-TB |
| Catalog Number | TMM5-TB |
| Lot Number | 0435 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-03-10 |