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Model Number DS960TS |
Device Problem
Degraded (1153)
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Patient Problems
Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457); Unspecified Ear or Labyrinth Problem (4474)
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Event Date 03/11/2022 |
Event Type
malfunction
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Event Description
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The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged cough, ear aches, nasal irritation, throat soreness.There was no report of serious or permanent 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 received new and relevant information on 02/13/2023 related to a cpap device's sound abatement foam alleging that patient having history of breathing issue and pneumonia.
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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 reported an allegation of an issue related to a bipap device's sound abatement foam and became degraded and caused the patient to have cough, ear aches, nasal irritation, throat soreness.The medical intervention that the patient received in response to the event is currently unknown.There was no report of serious 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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