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 2018-08-21 for VMAX ENCORE VMAX ENCORE 22 777404-101 manufactured by Vyaire Medical.
[117832673]
Vyaire file identification number (b)(4). The customer was requested to return the suspect device for investigation. At this time, the device has not been received by vyaire and an evaluation cannot be completed.
Patient Sequence No: 1, Text Type: N, H10
[117832674]
A customer reported to vyaire that the vmax encore system module made a loud noise followed by an ambient temperature warning and a smell consistent with electronics overheating and/or burning. The customer reported that there was no patient involvement and no harm to the end user associated with the reported problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2018-09221 |
| MDR Report Key | 7801157 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-21 |
| Date of Report | 2019-02-21 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2018-09-04 |
| Device Manufacturer Date | 2006-06-19 |
| Date Added to Maude | 2018-08-21 |
| 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 | MINDY FABER |
| Manufacturer Street | 26125 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 8727570116 |
| Manufacturer G1 | VYAIRE MEDICAL INC. |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| 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 | VMAX ENCORE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2018-08-21 |
| Returned To Mfg | 2018-08-22 |
| Model Number | VMAX ENCORE 22 |
| Catalog Number | 777404-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-21 |