MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-22 for TM-2100 TREADMILL manufactured by Critikon De Mexico S. De R.l. De C.v..
[29309691]
Ge healthcare? S investigation is ongoing. A follow up report will be submitted after the investigation has been completed. Patient data not provided due to country privacy laws. Initial reporter data not provided due to country privacy laws. Device manufacture date unknown.
Patient Sequence No: 1, Text Type: N, H10
[29309692]
It was reported that the treadmill conveyer belt started to move at an excessive speed, which caused the patient to fall down. The treadmill was repaired at the facility by a third party company. There was no serious injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008729547-2015-00015 |
| MDR Report Key | 5168957 |
| Date Received | 2015-10-22 |
| Date of Report | 2015-09-22 |
| Date of Event | 2015-09-16 |
| Date Mfgr Received | 2015-09-22 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2015-10-22 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JAMES GILES |
| Manufacturer Street | 3000 N GRANDVIEW BLVD, W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer G1 | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer City | JUAREZ 32575 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32575 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TM-2100 TREADMILL |
| Generic Name | POWERED TREADMILL |
| Product Code | IOL |
| Date Received | 2015-10-22 |
| Lot Number | SBC10166329SA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Address | CALLE VALLE EL CEDRO 1551 JUAREZ 32575 MX 32575 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-22 |