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 2018-04-18 for STATIC AND DYNAMIC COMPLIANCE 777404-101 manufactured by Vyaire Medical, Inc.
[105870760]
The reported issue was due to the patient falling on the mass flow sensor and breaking it. No further investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
[105870761]
The customer reported while using the vmax encore the patient performed a valsalva maneuver, experienced syncope and fell down. The customer reported that the patient grabbed the mass flow sensor while falling thus breaking it. The patient was sent to the emergency room as a precaution and no injury was noted at the time of the event. A replacement mass flow sensor was sent to the customer as a resolution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2018-07742 |
| MDR Report Key | 7441966 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2018-04-16 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2018-04-18 |
| 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 | 2018-04-18 |
| Catalog Number | 777404-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-04-18 |