Model Number DSX520H11C |
Device Problems
Degraded (1153); Mechanical Problem (1384); Device Emits Odor (1425)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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H3 other text : device not returned to manufacturer.
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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 (mw5149782).The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The manufacturer received information alleging a smell when i took of my cpap mask in the morning.I recently saw model is defective and emits a chemical.There was 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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Manufacturer Narrative
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In previous report b5, (device) problem code grid) (dpr-ppi-03-05-09), health impact grid and remedial action, recall (z) number was added incorrectly.In this report correction was made.
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Event Description
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The manufacturer received voluntary medwatch (mw5149782).The manufacturer received information alleging an issue related to a cpap device.The manufacturer received information alleging a smell when i took of my cpap mask in the morning.I recently saw model is defective and emits a chemical.There was 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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