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

Model Number DSX900T11C

Device Problem Degraded (1153)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 12/05/2022

Event Type  malfunction  

Event 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 an issue related to a bipap device's sound abatement foam.The patient has alleged visualization of particles in tubing/chamber, airways, nose and throat irritation.There was no report of permanent or serious 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 patient previously reported in event 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 an issue related to a bipap device's sound abatement foam.The patient has alleged visualization of particles in tubing/chamber, airways, nose and throat irritation.There was no report of permanent or serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete, which is updated as 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 an issue related to a bipap device's sound abatement foam.The patient has alleged visualization of particles in tubing/chamber, airways, nose and throat irritation.There was no report of permanent or serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.The date received by mfg is also updated and the coding are updated accordingly.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, 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 15208 ; 4125423300
• MDR Report Key: 15985787
• MDR Text Key: 305525254
• Report Number: 2518422-2022-101961
• 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

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1