MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DEX500S13

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Hemoptysis (1887); Unspecified Respiratory Problem (4464)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device has not been returned to manufacturer.

Event Description

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18356416
• MDR Text Key: 330889377
• Report Number: 2518422-2023-36590
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DEX500S13
• Device Catalogue Number: DEX500S13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other