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 2020-03-02 for 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) 3100 A 768901 manufactured by Vyaire Medical.
[184326606]
Biomed evaluated the device, it was visible in the initial investigation that device's power setting was set to 0. The field service representative ran the device for 8 hours and performed a patient circuit cal and vent performance check. As a resolution, the device was subjected to further testing including: dc power supply voltages check, calibration of airway pressure monitor xdcr, driver displacement indicator check and completed alarm tests. The fsr repeated patient circuit cal and vent performance check on the device. The unit was ready for patient use.
Patient Sequence No: 1, Text Type: N, H10
[184326607]
The customer reported that 3100a stopped oscillating while on a patient. The customer was suspecting a power supply issue. There was no patient harm with the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11451 |
| MDR Report Key | 9776157 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2004-06-30 |
| Date Added to Maude | 2020-03-02 |
| 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 | 2020-03-02 |
| Model Number | 3100 A |
| 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 | 2020-03-02 |