MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-13 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 29 UNIT ASSEMBLY 777497 manufactured by Carefusion, Inc.
[57397600]
(b)(4). No device or parts will not be returned to carefusion for evaluation at this time as the reported issue seems to be due to a software upgrade. The customer performed the software upgrade and the reported issue was resolved.
Patient Sequence No: 1, Text Type: N, H10
[57397601]
The customer reported that the treadmill has been stopping during testing while in use on a patient and using the cardio v6. 51 cam14 with usb.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-04637 |
| MDR Report Key | 6028289 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-13 |
| Date of Report | 2016-09-20 |
| Date of Event | 2016-09-20 |
| Date Mfgr Received | 2016-09-20 |
| Device Manufacturer Date | 2009-01-02 |
| Date Added to Maude | 2016-10-13 |
| 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 | 3 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-10-13 |
| Model Number | VMAX ENCORE 29 UNIT ASSEMBLY |
| Catalog Number | 777497 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2016-10-13 |