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 2020-01-10 for 3100A HFOV 768901 manufactured by Vyaire Medical.
[174662887]
The field service engineer (fse) went on-site to evaluate the suspect device. The fse cycled the device on and was able to duplicate the reported device behavior. The fse determined the likely cause of this failure was associated with user error and the equipment device was out of calibration.
Patient Sequence No: 1, Text Type: N, H10
[174662888]
The customer reported this ventilator device failed to cycle intermittently, while in patient use. The customer stated that no patient information regarding patient impact had been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11251 |
| MDR Report Key | 9578226 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2006-08-25 |
| Date Added to Maude | 2020-01-10 |
| 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 | MR. 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 | 3100A HFOV |
| Generic Name | VENTILATOR, HIGH FREQUENCY |
| Product Code | LSZ |
| Date Received | 2020-01-10 |
| Model Number | 3100A |
| Catalog Number | 768901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2020-01-10 |