MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-23 for TRANSMOTION MEDICAL, INC TMM5-TB manufactured by Transmotion Medical Inc..
[5426991]
Customer notified via e-mail that the device moved from a recline position to stretcher position. There was no injury that occurred and was notifying for information/service request only. No pt info was provided since there was not a reported injury.
Patient Sequence No: 1, Text Type: D, B5
[12785765]
The immediate action taken was to replace all of the customers pendants as they had a mix of new and old. Transmotion medical inc designed a new pendant which was released in 05/2013. The new pendant s considerably more durable than the older style pendants. The new pendant has been in production for 18 months and this is the first report of the new style pendant. Tmm is closely monitoring for additional, verifiable occurrences. Inspection and testing was completed by tmm on this specific pendant returned from the facility. The tmm pendant functioned as expected and the issue could not be duplicated. The only changes were the visible, external modifications the facility made themselves to the pendant to remove/adhere a holding clip. No significant environmental data when the event occurred, which could have contributed to the movement. Tmm believes this was actually attributed to skf's pendant, in which tmm already has an ongoing recall for the described event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2014-00005 |
| MDR Report Key | 4457734 |
| Report Source | 06 |
| Date Received | 2015-01-23 |
| Date of Report | 2015-01-22 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2014-12-12 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2015-03-02 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 442740302 |
| Manufacturer Country | US |
| Manufacturer Postal | 442740302 |
| 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 SURGICAL STRETCHER-CHAIR |
| Product Code | GBB |
| Date Received | 2015-01-23 |
| Model Number | TMM5-TB |
| Catalog Number | TMM5-TB |
| Lot Number | 3913 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2015-01-23 |