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Model Number FRX700S14 |
Device Problem
Degraded (1153)
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Patient Problems
Headache (1880); Numbness (2415); Cough (4457)
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Event Date 03/25/2022 |
Event Type
malfunction
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Event Description
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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 cpap device's sound abatement foam.The patient has alleged to headache,dry cough,allergy in eyes,throat tingling.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Manufacturer Narrative
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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 previously received information alleging an issue related to a bipap device's sound abatement foam.The patient has alleged to headache,dry cough,allergy in eyes,throat tingling.There was no report of patient harm or injury.There was no medical intervention required by the patient.The device was returned to third party service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device.The internal aspect of the device was evaluated and no contamination was observed.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were 04 errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit is scrapped.
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Search Alerts/Recalls
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