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Model Number DS560TS |
Device Problems
Thermal Decomposition of Device (1071); Degraded (1153); Melted (1385)
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Patient Problems
Headache (1880); Dizziness (2194)
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Event Date 02/28/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging device has strange odor, headaches, light headiness, device has strange odor, burning/smoke/electrical odor to a cpap device's sound abatement foam.There was no report of 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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The manufacturer previously reported a device allegedly having a strange odor, headaches, lightheadedness, device has strange odor, burning/smoke/electrical odor to a cpap device's sound abatement foam.There was no report of patient harm or injury.Manufacturer received additional information alleging the device's power cord is burnt, device/power cord or supply melted, and that the device will not turn on/device not functioning.The investigation is still ongoing.A follow up report will be filed when the manufacturer has completed the investigation.
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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 visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury. repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is 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.
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Search Alerts/Recalls
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