MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTOSV, DE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	DEX900S13
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Dyspnea (1816); Extreme Exhaustion (1843); Headache (1880); Nausea (1970)
Date of Event	04/10/2024
Type of Reportable Event	Death
Event or Problem Description
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 received information alleging exhaustion, nausea, headaches, shortness of breath, choking attacks, difficulty swallowing and death.In addition, patient alleges filters were completely black every morning.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
Corrected data: evaluation code grid: from device not returned to type of investigation not yet determined.Evaluation results code grid: from no findings available to results pending completion of investigation conclusion code grid: from cause not established to conclusion not yet available.
Additional Manufacturer Narrative
The device was returned to a third-party service center on (b)(6) 2024, but the investigation is still ongoing.
Additional Manufacturer Narrative
As per device evaluation received on 09/03/2024: the device "dreamstation autosv" was returned to the third party service center for evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and foam particles were not observed inside the assembly.In addition, dust/dirt was found inside the device.Additionally, the patient¿s complaint was not confirmed, and the device was scrapped.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.In this report, box d, h has been updated/corrected.

• Brand Name: DREAMSTATION AUTOSV, DE
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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 ; 7247330200
• MDR Report Key: 19145264
• Report Number: 2518422-2024-19758
• Device Sequence Number: 7833625
• Product Code: MNS
• UDI-Device Identifier: 00606959425781
• UDI-Public: (01)00606959425781
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/15/2025

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: DEX900S13
• Device Catalogue Number: DEX900S13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; 09/03/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/08/2024; 09/10/2024; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1973-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown