MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-02-16 for TRANSMOTION MEDICAL, INC. TMM4-WB manufactured by .
[2393430]
The initial report was stated as: female pt in the emergency dept was admitted onto one of our tmm4 series chairs. She was placed in by the staff and was going to need to wait 1+ hours to be treated. She was left in her treatment room while awaiting a physician. At this point, she stated that she attempted to "reposition herself," and at this time the chair tipped forward. When the chair tipped forward, the pt was injured during her fall. She reported to the hosp that she "re-aggravated a shoulder injury," as well as had contusions on her knee's. Additionally, she was experiencing neck and back pain.
Patient Sequence No: 1, Text Type: D, B5
[9712959]
Exact serial number was unk. Upon a detailed review at the facility on (b)(4) 2011, with the risk mgmt team, dept mgr, and tmm coo, it was noted that the pt was left in the chair for 1 - 1. 5 hours with the back section up, the leg section up, and the arm rails up. When the pt moved to exit the chair from the leg section, the chair tipped forward. Essentially the pt sat on a portion of the chair which is labeled "warning: do not stand or sit on footrest. " the pt was also not informed of how to ingress/egress. The facility did not file a voluntary 3500 form as they didn't' see it fit the requirement. Ultimately, the risk mgrs felt the alleged incident wasn't credible enough to warrant it. A re-inservice of the proper ingress/egress procedure were communicated on (b)(4) 2011. The pt was left alone in the chair without the proper instruction for ingress/egress, nor any assistance when she tried to do so. The stretcher-chair was misused, not defective.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2011-00001 |
| MDR Report Key | 2460646 |
| Report Source | 05 |
| Date Received | 2012-02-16 |
| Date of Report | 2011-12-16 |
| Date of Event | 2011-09-11 |
| Date Mfgr Received | 2011-10-08 |
| Device Manufacturer Date | 2008-06-12 |
| 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 | RISK MANAGER |
| 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 | 2012-02-16 |
| Model Number | TMM4-WB |
| Catalog Number | TMM4-WB |
| Lot Number | 2193 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-02-16 |