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Device Problem
Degraded (1153)
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Patient Problems
Abdominal Pain (1685); Headache (1880); Unspecified Respiratory Problem (4464)
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Event Date 08/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.
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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 voluntary medwatch (mw5102298).The patient has alleged of headache, stomach aches and sinus pressure issues.There was no report of serious or permanent patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Search Alerts/Recalls
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