MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-09-18 for TRANSMOTION MEDICAL INC. TMM5-XTB manufactured by Transmotion Medical Inc..
[4984896]
(b)(6) contacted her tmm sales rep (b)(4) stating that during an eye procedure, the tmm5 stretcher-chair started moving down on its own. (b)(6) did not indicate if the movement was in the back section or the column of the chair. (b)(6) is concerned that the other pendants on the other chairs in the facility will malfunction in the same manner injuring a patient. (b)(6) was asked for details about the patient and the incident but this info was not documented by the facility at the time of the incident. (b)(6) could not provide any other info other than the chair moved down on its own during the procedure with the pendant hanging or laying on the chair.
Patient Sequence No: 1, Text Type: D, B5
[12404268]
The immediate action taken was to replace all older style pendants with newly designed pendants for all devices in the facility. Earlier reports from this facility indicate that the pendants were being drug on the ground which could damage the pendant and cause a malfunction. The date of the incident is unk and documented as the date that the sales rep was informed of the incident. (b)(6) did not provide the specific date of the incident. (b)(6). Has designed a new pendant which was released in may of 2013. The new pendant is considerably more durable than the older style pendants. The new pendant has been in production for 17 months and a total of approx (b)(4) pendants are currently in the field. There have been no reports of the new pendant causing the device to move on its own.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2014-00001 |
| MDR Report Key | 4209316 |
| Report Source | 06 |
| Date Received | 2014-09-18 |
| Date of Report | 2014-09-17 |
| Date of Event | 2014-09-03 |
| Date Mfgr Received | 2014-09-03 |
| Device Manufacturer Date | 2012-06-27 |
| Date Added to Maude | 2014-10-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1440 WOLF CREEK TRAIL |
| Manufacturer City | SHARON CENTER OH 44274 |
| Manufacturer Country | US |
| Manufacturer Postal | 44274 |
| Manufacturer Phone | 3302394192 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSMOTION MEDICAL INC. |
| Generic Name | TMM5 MOBILE STRETCHER-CHAIR |
| Product Code | GBB |
| Date Received | 2014-09-18 |
| Model Number | TMM5-XTB |
| Catalog Number | TMM5-XTB |
| Lot Number | 4717 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1440 WOLF CREEK TRAIL SHARON CENTER OH 44274 US 44274 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-18 |