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 2018-02-02 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 22 777404-101 manufactured by Vyaire Medical, Inc.
[98997497]
(b)(4). The suspected device was received and a failure investigation was performed. The reported issue was confirmed and a burnt analyzer board during was found. Upon further investigation, the failure analysis technician found that the hex nut went through the tracing causing a short, due to a washer not being installed.
Patient Sequence No: 1, Text Type: N, H10
[98997498]
The customer reported that the vmax module is having intermittent issues with lung diffusion (dlco) testing. There was no patient involvement at the time of the reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2018-07374 |
| MDR Report Key | 7238567 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-02 |
| Date of Report | 2018-02-02 |
| Date of Event | 2017-05-18 |
| Date Mfgr Received | 2018-01-09 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2018-02-02 |
| 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 | 2018-02-02 |
| Returned To Mfg | 2017-06-12 |
| Model Number | VMAX ENCORE 22 |
| Catalog Number | 777404-101 |
| Device Availability | R |
| 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 | 2018-02-02 |