MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-12 for 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) 3100 A 768901 manufactured by Vyaire Medical.
[183135267]
The field service representative performed and completed several calibrations to this unit such as airway pressure monitor transducer, pneumatic check and/or adjustment, alarm function test, driver displacement indicator adjustment, driver controller adjustment, pulse width modulator (pwm) adjustment, patient circuit calibration and a performance test. There was no problem detected as the unit operates within specification. The field service representative recommends that the device must undergo for 12k/7yr preventive maintenance. Any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[183135268]
The customer reported all the settings on 3100a ventilator were drifting including the frequency while ventilating on a patient. The patient was transferred to another ventilator. At this time, patient harm is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11386 |
| MDR Report Key | 9701923 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2009-01-22 |
| Date Added to Maude | 2020-02-12 |
| 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 Phone | 8727570116 |
| 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 | 2020-02-12 |
| 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 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-12 |