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 2020-03-17 for 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) 3100B 770155 manufactured by Vyaire Medical.
[187730474]
(b)(4). The customer requested for a field service representative to go onsite to evaluate the ventilator. No root cause has been determined at this time, since investigation is still ongoing. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[187730475]
The customer reported that their 3100b ventilator only goes 20% it and won't budge. There is no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11545 |
| MDR Report Key | 9845789 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2004-03-19 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 7570116 |
| Manufacturer G1 | VYAIRE MEDICAL |
| 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 | 2020-03-17 |
| Model Number | 3100B |
| Catalog Number | 770155 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-17 |