MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for TRACKMASTER TMILL TMX-425C 776111-102 manufactured by Carefusion.
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(b)(4). This mdr is being submitted in response to a two year retrospective complaint review that was performed by carefusion to identify mdrs following the issuance of a (b)(4). The device was requested from the customer, to date it has not been received by carefusion for evaluation. Should additional information become available a supplemental report will be submitted. Carefusion continues to track and trend any incident related to this issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
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The carefusion field service engineer (fse) reported that the? Emergency? Stop switch was not operating as intended. The fse stated that it would not stay in the? Stop? Position. A return materials authorization (rma) was issued to the customer for the return of the product; to date the product has not been received by carefusion for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03157 |
| MDR Report Key | 5429602 |
| Date Received | 2016-02-10 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-04-23 |
| Date Mfgr Received | 2014-04-23 |
| Date Added to Maude | 2016-02-10 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149227830 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRACKMASTER |
| Generic Name | TREADMILL, POWERED |
| Product Code | IOL |
| Date Received | 2016-02-10 |
| Model Number | TMILL TMX-425C |
| Catalog Number | 776111-102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-10 |