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 2020-02-21 for 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) 3100A 768901 manufactured by Vyaire Medical..
[184804466]
The field service representative informed customer that the air noise coming from inside the vent is the cooling air passing through the driver assembly. We ran performance verification and all values were within specifications. Any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[184804467]
The customer reported to vyaire that the 3100a was alarming, like an air blowing the back. The customer advised that the patient was moved to another ventilator and there was no patient harm associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11424 |
| MDR Report Key | 9742209 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-21 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2013-12-12 |
| Date Added to Maude | 2020-02-21 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 7570116 |
| Manufacturer G1 | VYAIRE MEDICAL. |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA, IL |
| Manufacturer Country | US |
| 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 | 2020-02-21 |
| 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 | 26125 N. RIVERWOODS BLVD. METTAWA, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-21 |