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 2017-09-25 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 229E 777410-101 manufactured by Vyaire Medical, Inc.
[87864200]
(b)(4). Results of investigation: the device was evaluated by a vyaire medical engineer on-site. The engineer was able to duplicate the problem. The engineer identified the issue to the customer's process on using "patient demographic" function instead of the recommended work flow by using "find a patient" function. The issue was resolved by advising the customer on properly importing data from the microloop software to vmax software by using the "find a patient" function. A change to the software will be included in the next version to prevent the customer from using this process incorrectly.
Patient Sequence No: 1, Text Type: N, H10
[87864201]
The customer reported while uploading data to the vmax software version 28-5b, data was populated erroneously to a patient's test results. The issue occurred during patient use but there was no report of patient impact associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2017-06692 |
| MDR Report Key | 6892686 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-25 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-08-30 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2017-09-25 |
| 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 | KRISTIN GRAF |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | VYAIRE MEDICAL, 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, PREDICATED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2017-09-25 |
| Model Number | VMAX ENCORE 229E |
| Catalog Number | 777410-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-25 |