MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for T2100 TREADMILL 2024315-001 manufactured by Critikon De Mexico S. De R.l. De C.v..
[146651974]
Ge healthcare's investigation has been completed and it has been confirmed that this event occurred due to recall fmi (b)(4) was not performed on this treadmill, which was to replace the drive motor to correct the uncontrolled motion. Fmi (b)(4) was not applied because of the inability to locate the device. Ge healthcare made three mandatory attempts at the time fmi (b)(4) was executed to locate this device but was unsuccessful. To correct this issue, a new drive motor was installed, and the device was returned to the customer for clinical use. No further actions are needed.
Patient Sequence No: 1, Text Type: N, H10
[146651975]
This report summarizes 1 malfunction event. The customer alleges that the tm 2100 powered treadmill model number 2024315-001 sped up and then went in reverse. There was no patient on the treadmill at the time of the issue and therefore no injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008729547-2019-00003 |
| MDR Report Key | 8555978 |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-26 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-04-26 |
| 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 | YOUSSEF HALAS |
| Manufacturer Street | 8200 WEST TOWER AVENUE |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | T2100 TREADMILL |
| Generic Name | TREADMILL, POWERED |
| Product Code | IOL |
| Date Received | 2019-04-26 |
| Model Number | 2024315-001 |
| 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 DEL CEDRO 1551 JUAREZ 32575 MX 32575 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-26 |