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 information alleging an issue related to a bipap device's sound abatement foam.The patient alleged nose bleeds, nose would be dry and cracked, when using face mask, area where mask is placed would break out in boil like hives that would be pussy and bloody when popped.There was no report of serious or permanent patient harm or injury.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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