Datex-Ohmeda Panda Infant Warmer recalled for oxygen delivery error risk
Datex-Ohmeda Panda warmer recalled for oxygen concentration error
A blender component in certain Datex-Ohmeda Panda Freestanding Warmers can loosen over time, causing the device to deliver oxygen at a concentration that does not match the setting the user selected. This can result in infants receiving too much or too little oxygen, potentially causing harm.
- Check if your Panda warmer has a service blender M1091607-R installed during recent preventive maintenance.
- If affected, contact Datex-Ohmeda immediately for inspection and correction of the blender component.
- Do not operate the warmer if you suspect the blender knob is loose or if oxygen delivery seems inconsistent with your settings.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2359-2026More Datex-Ohmeda Inc recalls
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