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 2020-02-05 for 3100A VENTILATOR 3100 A 768901 manufactured by Vyaire Medical.
[177834477]
Vyaire complaint #: (b)(4). A vyaire field service representative went onsite and evaluated the ventilator. The calibration checks were performed and all passed. The ventilator was allowed to operate for over 1 1/2 hours and it did not show any variations on delta p. The field service representative confirmed the ventilator met all vyaire manufacturer specifications. 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
[177834478]
It was reported to vyaire that the 3100a ventilator was involved in an incident while in use on a patient. The staff noted the delta p dropped. It is unknown if any alarms occurred. The customer reported the patient had some deterioration and was moved to a new ventilator. Customer did not provide details on the deterioration but they indicated that the patient recovered. Additional information concerning the patient deterioration has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11364 |
| MDR Report Key | 9672436 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-09 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2013-05-13 |
| Date Added to Maude | 2020-02-05 |
| 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 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 7607787281 |
| 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 | 3100A VENTILATOR |
| Generic Name | VENTILATOR, HIGH FREQUENCY |
| Product Code | LSZ |
| Date Received | 2020-02-05 |
| 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 | 2020-02-05 |