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Model Number DS1060TS |
Device Problem
Degraded (1153)
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Patient Problems
Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
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Event Date 08/02/2023 |
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 information alleging the device is not blowing out the right pressure.The patient alleges having a hard time breathing due to device malfunction.The patient has congestive heart failure and sever sleep apnea.No medical intervention was specified.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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Manufacturer Narrative
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The manufacturer was previously 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 the device is not blowing out the right pressure.The patient alleges having a hard time breathing due to device malfunction.The patient has congestive heart failure and sever sleep apnea.No medical intervention was specified.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.A pms clinical expert review determined based on the information available at the time of the review, there is insufficient evidence to pronounce a serious injury.Corrections were made in this report for sections b: adverse event/product problem and in section h: health impact.A final report is being filed at this time.If any additional information is received, a supplemental report will be filed.
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Search Alerts/Recalls
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