MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-16 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 229 777400-101 manufactured by Carefusion, Inc.
[55259963]
(b)(4). Carefusion field service representative (fsr) was dispatched to perform an onsite evaluation. The fsr performed a firmware upgrade on the treadmill to 0. 4f. The fsr then performed an operation check and ran a custom protocol in order to verify the functionality of the treadmill. The testing was run five times and the reported issue was resolved. The treadmill is meeting all manufacture specifications no device or parts will be returned at this time.
Patient Sequence No: 1, Text Type: N, H10
[55259964]
The customer reported that while using the static and dynamic compliance, the track master treadmill tmx428cp stopped in the middle of a test. The customer reported seeing a? Tether error? Message. The reported issue occurred during preparation for use and there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-04453 |
| MDR Report Key | 5956492 |
| Date Received | 2016-09-16 |
| Date of Report | 2016-08-25 |
| Date of Event | 2016-08-25 |
| Date Mfgr Received | 2016-08-25 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2016-09-16 |
| 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 PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149227830 |
| Manufacturer G1 | CAREFUSION, INC |
| 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 | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-09-16 |
| Model Number | VMAX ENCORE 229 |
| Catalog Number | 777400-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-16 |