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

Model Number DSX900T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Cough (4457)

Event Date 07/20/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The patient alleged seeing paricles in the device.The patient alleged having phlegm in the throat.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer was previously 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 visualization of particles and phlegm in the throat related to a bipap device's sound abatement foam.There was no report of patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An internal visual inspection was completed by the manufacturer.Sound abatement foam degradation and breakdown was visibly observed in the base unit.Pil found sound abatement foam degradation throughout the blower box, on the inside surface of the blower upper cap, and where the blower rests in the blower box.A black tar-like substance was located on the inside surface of the blower and on the blower blades.A dark contamination was found on the inside surface of the lower enclosure which is consistent with sound abatement foam degradation.Pil can confirm sound abatement foam degradation.Pil is unable to assess the symptoms described in the complaint.Pil found that other contaminants located in this investigation were sourced from external environmental conditions.The device's downloaded event log was reviewed by the manufacturer and found no erros logged.The device was hooked up to power supply, airflow was verified and the device operated properly.The manufacturer concludes there were evidences of sound abatement foam degradation or breakdown.The manufacturer also confirmed the presence of multiple contaminants inside the device.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14748191
• MDR Text Key: 301594227
• Report Number: 2518422-2022-43537
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 07/10/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1