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

Model Number DSX700T11C

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Liver Damage/Dysfunction (1954); Nausea (1970); Pulmonary Dysfunction (2019); Vomiting (2144); Dizziness (2194); Respiratory Tract Infection (2420); Unspecified Kidney or Urinary Problem (4503); Skin Inflammation/ Irritation (4545)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer for analysis.

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.Per the legal department, the patient has alleged nose irritation, skin irritation, respiratory tract irritation, dizziness and/or headache, hypersensitivity, nausea/vomiting, asthma (new or worsening), inflammatory response, kidney disease/toxicity, liver disease/toxicity, lung disease, and allegation listed as "other." no other clinical information or medical intervention was specified.Three 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.

Manufacturer Narrative

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.Per the legal department, the patient has alleged nose irritation, skin irritation, respiratory tract irritation, dizziness and/or headache, hypersensitivity, nausea/vomiting, asthma (new or worsening), inflammatory response, kidney disease/toxicity, liver disease/toxicity, lung disease, and allegation listed as "other." no other clinical information or medical intervention was specified.Three 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.In the previous report, "product problem" was selected for box b: adverse event/product problem.The option "both" should have been selected along with the option "other" for outcomes attributed to ae.Both of these errors have been corrected on this report.

• Brand Name: DREAMSTATION AUTO BIPAP
• Type of Device: 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18700912
• MDR Text Key: 335292745
• Report Number: 2518422-2024-07280
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700T11C
• Device Catalogue Number: DSX700T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other