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 2019-05-10 for BLENDER 10047A manufactured by Vyaire Medical.
[144709263]
Vyaire medical received uf report: (b)(4). Vyaire medical, inc. Reached out to the customer to obtain additional information. The serial number was provided and confirmed. Based on the information provided in the uf report: (b)(4), the biomed reported the device was repaired and returned back to service.
Patient Sequence No: 1, Text Type: N, H10
[144709264]
The customer reported while undergoing extracorporeal membrane oxygenation (ecmo) post oxygenator therapy, the patient's partial-arterial oxygen (pa02) level is reading seventy (70) mmhg. The customer performed troubleshooting. The oxygen tubing and filter was changed. The customer reported no improvements to the patient were reported with the post oxygenator pa02 greater than 500 mmhg. The customer determined the most likely cause of the issue was due to the blender dial knob. The customer reported it found to be loose. The customer reported verified the device with an analyzer check and reported reading only twenty-one percent (21%) oxygen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2019-10245 |
| MDR Report Key | 8599906 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-10 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2014-06-23 |
| Date Added to Maude | 2019-05-10 |
| 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 | STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| 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 | BLENDER |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2019-05-10 |
| Model Number | BLENDER |
| Catalog Number | 10047A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-10 |