MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for OPTIFLOW THRIVE HIGH FLOW NASAL CANNULA manufactured by Fisher & Paykel Healthcare Limited.
[182975698]
The optiflow thrive is a combination of a reusable flow meter, blender, and warning plate and a disposable humidifier, tubing, and nasal cannula. The device was connected to the pt while the warmer was plugged in and turned off and flow was initiated through the blender. As a result, a high flow (60 liters per min) of oxygen at room temperature and without added humidification was delivered to the pt's nasal passages. This period lasted 17 mins while the pt was anesthetized until the device's "powered off" state was discovered. Upon wakening from anesthesia, the pt's nasal passages were swollen shut, and he experienced pain, ear plugging, and swollen tear ducts. The injury still affects the pt several weeks following the procedure. By design, the device can expose the pt to high flows of un-warmed, un-humidified air, as the device only creates an alarm if the power is turned on, but flow of gas through the device does not depend on the device being turned on. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093604 |
| MDR Report Key | 9805133 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-14 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLOW THRIVE HIGH FLOW NASAL CANNULA |
| Generic Name | CANNULA, NASAL, OXYGEN |
| Product Code | CAT |
| Date Received | 2020-03-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LIMITED |
| Manufacturer Address | PANMURE, AUCKLAND 1741 NZ 1741 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-06 |