MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-11-01 for STATIC AND DYNAMIC COMPLIANCE 777400-102 manufactured by Vyaire Medical, Inc.
[91201666]
Vyaire complaint #: (b)(4). Results of investigation: the vyaire factory service (fs) technician received the suspected device and performed a failure investigation. The reported issue was confirmed. The device would not power on. Also, a burnt analyzer board and solenoid cable were found during the investigation. It is unknown what the root cause of the failure is.
Patient Sequence No: 1, Text Type: N, H10
[91201667]
The customer reported that the vmax module absolutely failed to power on. There was no patient involvement at the time of the reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2017-06905 |
| MDR Report Key | 6994319 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-11-01 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2017-10-24 |
| Device Manufacturer Date | 2004-12-01 |
| Date Added to Maude | 2017-11-01 |
| 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 | 2017-11-01 |
| Returned To Mfg | 2017-10-10 |
| Catalog Number | 777400-102 |
| 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 | 2017-11-01 |