MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-03 for 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) 3100A 768901-RFB manufactured by Vyaire Medical.
[184324302]
Vyaire evaluate device onsite found out vent has no support arm. The circuit was disconnected where the support arm would be located. Excess water in the circuit cause map (main airway pressure) fluctuations. The customer was using low flow blender which is not recommended for ventilator use. Vyaire replaced circuit and retested system no other problems noted. The power module was replaced and performed 7 year pm. Completed performance test on the ventilator no other problems noted.
Patient Sequence No: 1, Text Type: N, H10
[184324303]
The customer reported that the 3100a map (main airway pressure) was fluctuating and the amp reading is 2. The device was running on a patient and was transferred to another ventilator. Customer confirmed no patient harm in this reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11481 |
| MDR Report Key | 9780500 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2013-11-26 |
| Date Added to Maude | 2020-03-03 |
| 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 | MS. MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| 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 | 2020-03-03 |
| Model Number | 3100A |
| Catalog Number | 768901-RFB |
| 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 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-03 |