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Model Number DEX500S13 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
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Patient Problems
Hemoptysis (1887); Unspecified Respiratory Problem (4464)
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Event Date 12/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3 other text : device has not been returned to manufacturer.
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Event Description
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The manufacturer received information in reference to a dreamstation auto cpap/heated humidifier sn device.The manufacturer became aware of an allegation a user of a resmed airsense 10 is having similar health problems to the ones they had while using his/her philips dreamstation auto cpap device.The user stated he/she is unsure exactly when the problems started, but alleged having a purulent, bleeding cough without any diagnosis or source of infection or blood evidence which could be causing the symptoms in the lungs and sinuses.The user has been seen by infectious disease doctors, the sleep laboratory, and several ear, nose, and throat doctors.The user alleged being prescribed many antibiotic treatments because the mucous membranes of the nasal and paranasal sinuses were constantly inflamed causing secretions to enter the lungs at night.Imaging studies revealed a remarkable shadow in the lungs, which healed again after strong antibiotics were prescribed.The user states unfortunately the infections continue, and he/she did not have this before using the devices.The user reported having the most expensive disinfection devices and stated the tubes are sterilized daily, including the water tank.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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Event Description
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The manufacturer received information in reference to a dreamstation auto cpap/heated humidifier device.The sn of the heated humidifier is h206795231eab.The manufacturer became aware of an allegation a user of a resmed airsense 10 is having similar health problems to the ones they had while using his/her philips dreamstation auto cpap device.The user stated he/she is unsure exactly when the problems started, but alleged having a purulent, bleeding cough without any diagnosis or source of infection or blood evidence which could be causing the symptoms in the lungs and sinuses.The user has been seen by infectious disease doctors, the sleep laboratory, and several ear, nose, and throat doctors.The user alleged being prescribed many antibiotic treatments because the mucous membranes of the nasal and paranasal sinuses were constantly inflamed causing secretions to enter the lungs at night.Imaging studies revealed a remarkable shadow in the lungs, which healed again after strong antibiotics were prescribed.The user states unfortunately the infections continue, and he/she did not have this before using the devices.The user reported having the most expensive disinfection devices and stated the tubes are sterilized daily, including the water tank.The device has not yet been returned to the manufacturer for investigation.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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B5-the manufacturer previous reported receiving information in reference to a dreamstation auto cpap/heated humidifier sn device.The sn was previously omitted in the initial report.The corrected statement in b5 should read as follows to include the sn of the heated humidifier: the manufacturer received information in reference to a dreamstation auto cpap/heated humidifier device.The sn of the heated humidifier is h206795231eab.Additionally, the manufacturer previously reported in box e the reporter country as germany.The correct reporter country is austria.The manufacturer has updated sections b5 and e1 in this report.
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Search Alerts/Recalls
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