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 2017-09-12 for VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS VMAX ENCORE 229C 777410-101 manufactured by Vyaire Medical, Inc.
[85804849]
(b)(4). At this time, vyaire has not received the suspect device/component for evaluation. If additional information becomes available, it will be submitted in a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[85804850]
A customer reported to vyaire medical that, when toggling the cart power supply switch to the vmax encore 229c pulmonary function testing system, a spark was observed, which the customer felt and described as equivalent to a discharge of static electricity when touching something in a dry environment. The customer did not seek medical treatment and did not suffer any effects due to the shock. The system was not in use on a patient when the problem occurred. The customer was advised by vyaire medical technical support not to use the system until an evaluation by a field service representative (fsr) could be performed. The customer reported that they continue to use the system with no reoccurrence of the reported problem. A service visit by a vyaire field service representative has been scheduled to evaluate the system.
Patient Sequence No: 1, Text Type: D, B5
[113452990]
A field service representative (fsr) performed service and replaced the isolation transformer and made necessary adjustments. The fsr noted that the customer will return the suspect isolation transformer to vyaire for evaluation. Vyaire has not received the device for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[113684267]
The device was returned to vyaire and an investigation was performed by the failure analysis lab. The original complaint was duplicated and the device was found to have a failed on/off switch. The failure is considered an isolated incident and no corrective action is indicated at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2017-06610 |
| MDR Report Key | 6858969 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-12 |
| Date of Report | 2017-11-30 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2017-09-12 |
| 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 |
| 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 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2017-09-12 |
| Model Number | VMAX ENCORE 229C |
| Catalog Number | 777410-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-09-12 |