MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-02-03 for TRANSMOTION MEDICAL, INC. TMM4-XWTRFB manufactured by .
[21357720]
A full written report was requested from the facility regarding the incident on two occasions (b)(6) 2012 and we have yet to receive. Therefore, the details of the age/weight of the patient are not exactly known as different answers were provided from different members of the staff. An initial inspection was conducted by (b)(4) (tmm sales representative) on (b)(4) 2012, along with (b)(4), and nothing was found to be wrong with the chair. The chair was inspected by (b)(4) on (b)(4) 2012, while on-site at (b)(6) memorial. The chair was fully functional and no issue was found with the back actuator. The only possibly scenario is that the patient or caregiver accidentally pulled this lever causing the back section to drop as designed. The patient was not wearing the safety strap. An inspection letter was sent to (b)(4) via email on (b)(4) 2012, stating the chair was fully functional.
Patient Sequence No: 1, Text Type: N, H10
[21459730]
The product was in a recline position and it suddenly went into trendelenburg position. The patient slid down the surface and hit her head against the wall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004082462-2012-00001 |
| MDR Report Key | 2493875 |
| Report Source | 05 |
| Date Received | 2012-02-03 |
| Date of Report | 2012-01-30 |
| Date of Event | 2012-01-05 |
| Date Mfgr Received | 2012-01-05 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-07-30 |
| 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 44274 |
| Manufacturer Country | US |
| Manufacturer Postal | 44274 |
| Manufacturer Phone | 3302394192 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSMOTION MEDICAL, INC. |
| Generic Name | TMM4 SERIES MULTI-PURPOSE STRETCHER/CHAI |
| Product Code | GBB |
| Date Received | 2012-02-03 |
| Model Number | TMM4-XWTRFB |
| Catalog Number | TMM4-XWTRFB |
| Lot Number | 3990 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-03 |