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 2019-02-15 for STATIC AND DYNAMIC COMPLIANCE PHYSICIAN CHOICE ENCORE TOWER 777543-102 manufactured by Vyaire Medical.
[136526756]
(b)(4). The suspected device was received and a failure investigation was conducted. The reported issue was confirmed and a damaged (burnt) contact was found on the isolation transformer's switch. This issue will be internally investigated within vyaire.
Patient Sequence No: 1, Text Type: N, H10
[136526757]
The customer initially reported the static and dynamic compliance vmax device was unable to power on. The customer in conjunction with the field service representative determined the most likely caused of event vmax cart. Customer reported there was no patient involvement with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2019-09890 |
| MDR Report Key | 8345688 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-08-22 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2010-04-22 |
| Date Added to Maude | 2019-02-15 |
| 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 | STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| 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 | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2019-02-15 |
| Returned To Mfg | 2018-09-19 |
| Model Number | PHYSICIAN CHOICE ENCORE TOWER |
| Catalog Number | 777543-102 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |