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 2018-05-23 for STATIC AND DYNAMIC COMPLIANCE PHYSICIANS CHOICE ENCORE 777544-102 manufactured by Vyaire Medical, Inc.
[109105936]
(b)(4). As the correction for this event, the vyaire medial field service engineer installed a replacement module during an onsite visit. Results of investigation: the suspected device was received and a failure investigation was performed. The reported issue was confirmed and a burnt analyzer board was found. Upon further investigation, the failure analysis technician found there was shorted to ground by the pneumatic control board assembly mounting hardware. Several attempts have been made to contact the customer for additional information. At this time, the customer has not responded to any contact attempts and vyaire medical is unable to confirm the customer's reported device issue.
Patient Sequence No: 1, Text Type: N, H10
[109105937]
The customer initially reported the static and dynamic compliance vmax device was showing lower than expected residual volume values.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2018-07897 |
| MDR Report Key | 7539370 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-23 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-05-07 |
| Device Manufacturer Date | 2011-08-23 |
| Date Added to Maude | 2018-05-23 |
| 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 | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICATED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2018-05-23 |
| Returned To Mfg | 2018-01-17 |
| Model Number | PHYSICIANS CHOICE ENCORE |
| Catalog Number | 777544-102 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-05-23 |