MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-10-24 for TM-2000 manufactured by Critikon De Mexico.
[20266555]
This customer reports that a patient was beginning a stress test, lost their balance, and hit their chest on the front bar. It was reported that the patient did crack costal cartilage and would require four weeks to heal. No reported intervention was required and the exam was reported to be completed.
Patient Sequence No: 1, Text Type: D, B5
[20496716]
(b)(4): manufacture date is unknown at this time. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[23578818]
Investigation revealed the device performed properly. Probable root cause: patient lost balance and fell.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2014-00011 |
| MDR Report Key | 4199656 |
| Report Source | 01 |
| Date Received | 2014-10-24 |
| Date of Report | 2014-09-29 |
| Date of Event | 2014-09-17 |
| Date Mfgr Received | 2014-12-01 |
| Date Added to Maude | 2014-10-24 |
| 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 Contact | DEB LAHR |
| Manufacturer Street | 540 W. NORTHWEST HWY |
| Manufacturer City | BARRINGTON IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer Phone | 8472774472 |
| Manufacturer G1 | CRITIKON DE MEXICO |
| Manufacturer Street | S. DE R.L. DE C.V. |
| Manufacturer City | JUAREZ, |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TM-2000 |
| Generic Name | TREADMILL, POWERED |
| Product Code | IOL |
| Date Received | 2014-10-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITIKON DE MEXICO |
| Manufacturer Address | S. DE R.L. DE C.V. JUAREZ, MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-24 |