MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-05-21 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 22 D 777405-103 manufactured by Vyaire Medical, Inc.
[108778179]
Several attempts have been made to contact the customer for additional information and to evaluate the suspect device for the reported issue. At this time, the customer has not responded to any contact attempts and vyaire medical has not received the suspected device for evaluation. Upon completion of a final evaluation, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[108778180]
Our business partner from (b)(6) reported while using static and dynamic compliance; the staff employees are reporting symptoms of malaise and fatigue. The respiratory laboratory of clinic golnik performed control measurement of carbon monoxide (dlco) and found the dlco measurement is above the limit values inside the laboratory. The customer reported using two dlco gases per vmax unit each month. The customer reported during the winter season, there are only two windows which are kept closed and no additional ventilation is provided. The customer reported staff employees are known smokers. In addition, one of the employees discovered aneurysm and breast cancer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615102-2018-00002 |
| MDR Report Key | 7529947 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-21 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-06-07 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2018-05-21 |
| 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, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2018-05-21 |
| Model Number | VMAX ENCORE 22 D |
| Catalog Number | 777405-103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-21 |