RESPIRONICS, INC. REMSTAR PLUS C-FLEX W/HUMID, SD CARD; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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Model Number DS250HS |
Device Problems
Degraded (1153); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
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 patient alleges foam particles in the device.No patient harm or injury allegation.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 was previously 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 patient alleges foam particles in the device.No patient harm or injury allegation.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.The manufacturer received new information that the patient actually did not found any particles in the device.
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Search Alerts/Recalls
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