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 2020-02-18 for 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV 3100A 768901 manufactured by Vyaire Medical.
[180723042]
Vyaire technician cleaned the ventilator, replaced driver, installed preventive maintenance kit and calibrated the unit. Ventilator passed all performance check and no problem found.
Patient Sequence No: 1, Text Type: N, H10
[180723043]
The customer reported that their 3100a ventilator was involved in an incident while ventilating on a patient, they removed the ventilator and suctioned the patient. When they reconnected the ventilator to the patient, the unit would not start. The ventilator pressurized and started when the stopper was in circuit; they reconnect it to the patient and the ventilator did not start. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11372 |
| MDR Report Key | 9722850 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 1999-06-28 |
| Date Added to Maude | 2020-02-18 |
| 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 |
| 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 INC. |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS, CA |
| 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 | 2020-02-18 |
| 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 | 2020-02-18 |