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Model Number DSX900H11C |
Device Problem
Fire (1245)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/23/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging of a thermal event to a dreamstation bipap autosv device.The user alleges the device caught fire.There was no report of patient harm or injury.The manufacturer contacted the supplier for additional information and the customer did not report a thermal event to the supplier.Despite multiple attempts to contact the user, no further information is available.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.
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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 thermal event related to a bipap device's sound abatement foam.The user alleges the device caught fire.There was no report of patient harm or injury.After the second attempt to have the device and components returned for evaluation, customer stated that currently not using the device so the device won't available for return.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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