MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION CPAP PRO W/HUM/HT/CELL, AUS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AUX400T15C
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Inflammation (1932); Vomiting (2144); Respiratory Tract Infection (2420); Neck Pain (2433); Unspecified Blood or Lymphatic problem (4434); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient developed sinus infections and vomiting.The patient did receive medical intervention in the form of prescribed antibiotics and nasal sprays.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported information in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.Additional information was received that the patient is also alleging inflamed nerve endings in teeth, feeling unwell, blood poisoning and neck surgery while using the device.Patient alleged the device is poisoning him.The allegations of inflamed nerve endings, neck surgery, and blood poisoning were reviewed by the post market surveillance clinical experts and the events are assessed as not related to the device.Underlying health conditions as well as updated manufacturer contact information has also been provided.Please see sections b7, g1 and h6 for this updated information.The previous report was also filed as a follow up/final, however the manufacturer's investigation is now ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The updated coding in h6 reflects this change.
Additional Manufacturer Narrative
The manufacturer previously received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and the patient developed sinus infections and vomiting.The patient did receive medical intervention in the form of prescribed antibiotics and nasal sprays.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.The manufacturer has updated h6 in this report.

• Brand Name: DREAMSTATION CPAP PRO W/HUM/HT/CELL, AUS
• Common Device Name: 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7243512041
• MDR Report Key: 12308199
• Report Number: 2518422-2021-03036
• Device Sequence Number: 14443734
• Product Code: BZD
• UDI-Device Identifier: 00606959034792
• UDI-Public: 00606959034792
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: AUX400T15C
• Device Catalogue Number: AUX400T15C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 01/04/2023; 11/05/2025
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/13/2021; 01/09/2023; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male