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 2018-03-26 for BIRD HIGH FLOW BLENDER SERIES 03800A manufactured by Vyaire Medical, Inc.
[103460857]
At this time, vyaire has not received the suspect device from the customer for evaluation. Several attempts have been made to contact the customer for additional information and to evaluate the suspect device for the reported issue. At this time, the customer has not responded to any contact attempts and vyaire medical is unable to confirm the customer's reported device issue. In the event the device is received for evaluation or additional information is received a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[103460858]
The customer reported the bird high flow blender series was set to dispense oxygen at fifty-five percent. The customer reported the oxygen percentage was analyzed with a calibrated analyzer and was shown to be seventy-seven percent. The customer reported the blender was removed from service and was replaced with another blender. The issue occurred during patient-use; the customer reported there is no patient consequence associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2018-07611 |
| MDR Report Key | 7370489 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-26 |
| Date of Report | 2018-03-26 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2018-03-05 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2018-03-26 |
| 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 | KRISTIN GRAF |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | 1100 BIRD CENTER DR. |
| 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 | BIRD HIGH FLOW BLENDER SERIES |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2018-03-26 |
| Model Number | BLENDER |
| Catalog Number | 03800A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-26 |