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Model Number DSX500H11C |
Device Problems
Degraded (1153); Material Erosion (1214)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2023 |
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 visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.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 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 visualization of particles in the air path.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.According to information received during a good faith effort, the user alleges the device's power cord plug "erroded" and the machine will no longer power on.The user alleges that the machine has residue and build up.The manufacturer representative has updated the coding to include the erosion of the power cord.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Search Alerts/Recalls
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