MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for TUBING HIGH FLOW NASAL CANNULA HEATER manufactured by Hamilton Medical Ag.
[184270524]
Nurse to room, due to low sats. Tubing that connects from flowmeter to hamilton heater noted to have kink due to design that requires tubing to lay straight up. Tubing changed by respiratory and manipulated to not kink. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093821 |
| MDR Report Key | 9848126 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-14 |
| Date Added to Maude | 2020-03-18 |
| 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 | TUBING HIGH FLOW NASAL CANNULA HEATER |
| Generic Name | HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER) |
| Product Code | BZE |
| Date Received | 2020-03-17 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAMILTON MEDICAL AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |