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. TMM4BT manufactured by Transmotion Medical Inc..
[5034928]
Tmm notified via voice mail on (b)(6) 2014 by (b)(4) that an unattended icu pt fell out the front (foot section) of the chair. The root cause was the pt egressed from the front the device instead of a side ingress/egress, which is standard protocol. The chair tipped up and the pt fell on the floor. Exact circumstances of how this occurred are unk as no medical personnel witness the adverse event. Advocate stated that a subsequent medical eval yielded no serious injuries.
Patient Sequence No: 1, Text Type: D, B5
[12585970]
(b)(4) stated a preliminary investigation by advocate biomed was completed and felt the chair was working as it should. A tmm representative promptly reviewed the equipment on 11/05/2014 and a confirmatory inspection by also found it to be in good working condition. As this pt was unattended, it is not clearly understand of how the pt was using the device. Tmm clearly states in all of our training materials that the ingress/egress protocol is from the side, and not the front. Third party, (b)(4) load testing verifies the safe and effective stability testing of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2014-00003 |
| MDR Report Key | 4279073 |
| Report Source | 06 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-11-14 |
| Date of Event | 2014-10-23 |
| Date Mfgr Received | 2014-11-03 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2014-11-28 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSMOTION MEDICAL, INC. |
| Generic Name | TMM4 MULTI-PURPOSE STRETCHER-CHARI |
| Product Code | GBB |
| Date Received | 2014-11-20 |
| Model Number | TMM4BT |
| Catalog Number | TMM4BT |
| Lot Number | 0757 |
| Operator | LAY USER/PATIENT |
| 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 |