MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-01 for 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) 3100A 768901 manufactured by Vyaire Medical Inc..
[184315446]
(b)(4). Any additional information received from the customer will be included in a follow-up report. Field service representative noted that there is no internal leak. The loud cooling gas noise is due to out of calibration regulator. Regulator was calibrated and verified performance. The unit passed all performance check.
Patient Sequence No: 1, Text Type: N, H10
[184315447]
The customer reported that their 3100a has large internal leak. The customer claimed that there is unusual sound coming from internal component of the ventilator. There is no patient involvement associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11303 |
| MDR Report Key | 9656364 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-01 |
| Date of Report | 2020-01-03 |
| Date of Event | 2020-01-03 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2009-03-16 |
| Date Added to Maude | 2020-02-01 |
| 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 N. 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 | 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) |
| Generic Name | VENTILATOR, HIGH FREQUENCY |
| Product Code | LSZ |
| Date Received | 2020-02-01 |
| 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 INC. |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-01 |