MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-07 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 229 777400-101 manufactured by Carefusion, Inc.
[49021445]
(b)(4). At this time, carefusion has not received the suspect device/component for evaluation but a carefusion field service engineer (fse) has been dispatched to perform an onsite evaluation. Upon completion of a final evaluation, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[49021446]
The customer reported while using the static and dynamic compliance; the treadmill stops within different protocols without warning. The issue occurred during patient use; the customer reported no patient injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[51144933]
The carefusion field service engineer (fse) on site performed testing and confirmed the reported issue. The fse re-installed the cardiosoft v6. 51 software and the customer performed calibration. The unit is meeting carefusion specifications. Due to the event being resolved by re-installing the software; no parts will be sent back to carefusion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2016-04029 |
| MDR Report Key | 5777562 |
| Date Received | 2016-07-07 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-06-16 |
| Date Mfgr Received | 2016-07-09 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2016-07-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 DR. |
| 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 | 2016-07-07 |
| Model Number | VMAX ENCORE 229 |
| Catalog Number | 777400-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Other | 2016-07-07 |