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

Model Number	INX500S15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Unspecified Respiratory Problem (4464); Unspecified Gastrointestinal Problem (4491); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to the device's sound abatement foam.There was no patient harm or injury.The manufacturer's investigation in on-going.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.
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 received information alleging an issue related to a cpap device's sound abatement foam.The customer had alleged to have black powder blowing out of the device.There was no report of serious patient harm or injury.In the initial report, the patient's allegation of feeling unwell with her stomach and nose was inadvertently omitted.There was no report of medical intervention.The manufacturer has corrected the health effect clinical code and health effect impact code in this report.The device was returned to a third-party service center for investigation.During the evaluation of the device, the third-party service center visually inspected the device and did not note any finding of sound abatement foam degradation.The device did not pass final testing.The device was scrapped.The manufacturer has updated h6 in this report.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 12347163
• Report Number: 2518422-2021-03354
• Device Sequence Number: 14703063
• Product Code: BZD
• UDI-Device Identifier: 00606959025875
• UDI-Public: 00606959025875
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: INX500S15
• Device Catalogue Number: INX500S15
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 08/26/2022
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/03/2021; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2018
• 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
• Patient Sex: Unknown