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Model Number DSX500H11C |
Device Problems
Thermal Decomposition of Device (1071); Corroded (1131); Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2023 |
Event Type
malfunction
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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 cpap device's sound abatement foam.There was no patients harm or injury.Patient mailed in stating that her device power port is burned or rusted.There is no allegation of serious or permanent harm or injury.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.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 : device has not been returned to the manufacturer.
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Manufacturer Narrative
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Upon review of this complaint, there was no alleged serious injury.In addition, the malfunction will not cause or contribute to a serious injury if the event were to reoccur.This complaint does not meet the definition of a reportable event.
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Search Alerts/Recalls
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