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Model Number DSX500T11C |
Device Problems
Degraded (1153); Noise, Audible (3273)
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Patient Problem
Chest Pain (1776)
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Event Date 06/15/2021 |
Event Type
Injury
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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 dreamstation auto cpap device's sound abatement foam.The patient has alleged the device is making noise like the horn and causing her to have sharp pain in her chest, has noticed when she is on the machine she is having more pain and she has been having sharp chest pains after usage.Also stated had to change tubing because it was bothering her.Medical intervention happened, at emergency room of hospital patient stated that she was instructed to take bayer aspirin for the pain.No serious patient harm or injury reported.The device has not yet been returned to the manufacturer for investigation.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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H3 other text : not returned to manufacturer.
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Manufacturer Narrative
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Previously, the manufacturer received information alleging an issue related to a dreamstation auto cpap device's sound abatement foam.The patient has alleged the device is making noise like the horn and causing her to have sharp pain in her chest, has noticed when she is on the machine she is having more pain and she has been having sharp chest pains after usage.Also stated had to change tubing because it was bothering her.Medical intervention happened, at emergency room of hospital patient stated that she was instructed to take bayer aspirin for the pain.No serious patient harm or injury reported.Now, the manufacturer alleging that the allegation is serious injury and submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Corrected section b1 from product problem to both.B2 selected as other.Section selected as serious injury, h6 has been updated/corrected.In addition, appropriate code updated/ corrected.
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Search Alerts/Recalls
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