RESPIRONICS, INC. DREAMSTATION AUTO CPAP W/ HUM/CELL, DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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Model Number DSX500H11C |
Device Problems
Fire (1245); Smoking (1585)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2021 |
Event Type
malfunction
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Event Description
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The manufacturer became aware of an alleged thermal event to a dreamstation auto cpap.The user alleges that the device was leaking water, so the device was placed in a baking dish.The water in the dish is reported to have reached the power inlet port and caused a thermal event.There were reports of smoke and flames.No patient harm or injury was reported.The manufacturer has requested the return of the device.The investigation is on-going.On completion of the manufacturer's investigation, a follow up report will be filed.
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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 the device was leaking water, so the device was placed in a baking dish.The water in the dish is reported to have reached the power inlet port and caused a thermal event.There were reports of smoke and flames related to a cpap device's sound abatement foam.There was no report of 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.Section e1, h7, h9 have been updated (missed to update in the initial mdr) and section h6 updated in this report.
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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 the device was leaking water, so the device was placed in a baking dish.The water in the dish is reported to have reached the power inlet port and caused a thermal event.There were reports of smoke and flames related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for further evaluation. the device was evaluated.There was no mention of visual findings to the external part of the device. the internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found. the manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit is scrapped.In this report, section d9, g3, h3, h6 has been updated.
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