MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-13 for TRANSMOTION MEDICAL, INC. TMM5-WB manufactured by Transmotion Medical Inc..
[2998692]
This is a retroactive mdr report recommended by previous on-ste fda audit. This was the information that was presented in (b)(6) medwatch voluntary reporting form by (b)(6) on (b)(6) 2010: patient changed into gown and got into stretcher. Stretcher back was inclined 30 degrees, foot rest portion was flat, 0 degree angle from the seat portion. Patient sat down on the stretcher, was fully lying down cooperatively. At this point, the stretcher apparently tilted on the two headward wheels, the two footward wheels came up off the ground, and the backrest of the stretcher made contact with either the floor or the back of the wall in the pre-op bay. The patient remained in the chair throughout this incident. The nurse lifted the back of the chair back up, so that all four wheels could make full contact with the floor again. The patient suffered a minor abrasion to his shoulder, but was otherwise uninjured.
Patient Sequence No: 1, Text Type: D, B5
[10318913]
The device was inspected and nothing at all was found to be deficient with the device. Some information must not have been fully reported, as the chair would only tip if the patient's weight was put on the head end, and the warning labels would have been ignored. Since this is a retroactive report, we've been able to monitor. No other patient issues have been reported. No other modifications are needed to the chair and the device was in-serviced again for training purposes after the event to assure the staff doesn't run into the same issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2012-00004 |
| MDR Report Key | 2844985 |
| Report Source | 06 |
| Date Received | 2012-11-13 |
| Date of Report | 2012-11-12 |
| Date of Event | 2010-04-22 |
| Date Mfgr Received | 2010-05-04 |
| Device Manufacturer Date | 2008-11-01 |
| Date Added to Maude | 2012-12-12 |
| 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 |
| 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 | 2012-11-13 |
| Model Number | TMM5-WB |
| Catalog Number | TMM5-WB |
| Lot Number | 2568 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2012-11-13 |