MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-07 for TM-2100 manufactured by Critikon De Mexico S. De R.l. De C.v..
[32811853]
Patient information currently unavailable. Incident date unknown. Ge healthcare's investigation is on-going. A follow-up report will be submitted when the investigation is complete. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[32811854]
The customer reported that the patient stopped walking as the treadmill continued to move, the patient fell and broke their leg. No additional information has been able to be obtained regarding patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[36622505]
The treadmill tdu log file was reviewed and confirmed normal operation with no errors present. There was also no indication of an emergency stop being pressed on the reported incident date. Patient data or the printout of the patient test record was requested, but that request was denied. The root cause is use error. The investigation supports the hospital? S conclusion that the patient stopped walking on a moving belt causing them to fall off the back of the treadmill and be injured. The patient did not step off the belt onto the non-moving foot rests on the side of the belt. No defects were found within the treadmill that would have contributed to this event. There is no evidence of unusual treadmill behavior that contributed to the patient fall. Additional information: (b)(6). The patient broke an arm, not a leg as first indicated.
Patient Sequence No: 1, Text Type: N, H10
[36622506]
The customer reported that the patient stopped walking as the treadmill continued to move, the patient fell and broke their arm. No additional information has been able to be obtained regarding patient treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008729547-2015-00018 |
| MDR Report Key | 5271259 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-07 |
| Date of Report | 2015-11-10 |
| Date of Event | 2015-08-27 |
| Date Mfgr Received | 2016-01-08 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2015-12-07 |
| 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 | NUCLEAR MEDICINE TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DEB LAHR |
| Manufacturer Street | 540 W. NORTHWEST HWY. |
| Manufacturer City | BARRINGTON IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer G1 | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Street | CALLE VALLE EL CEDRO 1551 |
| Manufacturer City | JUAREZ 32575 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32575 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TM-2100 |
| Generic Name | POWERED TREADMILL |
| Product Code | IOL |
| Date Received | 2015-12-07 |
| Model Number | TM-2100 |
| Lot Number | SBC12059041SA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-12-07 |