The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received voluntary medwatch (mw5146859).The manufacturer received information alleging an issue related to a dreamstation bipap autosv device's sound abatement foam.The patient has alleged he cannot get rid of cough and noticed white particles in the water.In addition, patient stated that they have stopped using the device and is asking for new machine and compensation for all their troubles.Doctor on behalf of patient asked for replacement but still they have not received the unit.There was no report of serious or permanent patient harm or injury.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|