MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-05 for LOW FLOW AIR/OXYGEN MICROBLENDER LOW FLOW BLENDER 10011A manufactured by Vyaire Medical.
[177950907]
Any additional information received from the customer will be included in a follow-up report. At this time, the suspect device has not been evaluated yet. Therefore, no root cause could be determine yet. Once the evaluation is complete, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[177950908]
The customer reported that the patient was born with respiratory insufficiency and was provided mask to nasal cpap and aided by surfactants. Due to the need for increased oxygenation, the patient was then intubated and transferred to an infant resuscitator with blender. However, the patient continued to have low o2 saturation despite troubleshooting and increased inspiratory pressure, so the end user directly connected the hose to the oxygen outlet which stabilized the condition. Later on, the patient was transferred to a tertiary hospital with an undergoing investigation regarding patient harm. In addition, the customer reported that the blender was inspected and showed that it only provided 21% oxygenation regardless of the setting and the knob can be turned 360 degrees without barrier between 21% and 100%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11370 |
| MDR Report Key | 9673016 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2012-11-30 |
| 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 |
| 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 | LOW FLOW AIR/OXYGEN MICROBLENDER |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2020-02-05 |
| Model Number | LOW FLOW BLENDER |
| Catalog Number | 10011A |
| 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 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-05 |