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

Model Number DSX600H11

Device Problem Degraded (1153)

Patient Problems Pulmonary Dysfunction (2019); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464)

Event Date 01/04/2024

Event Type  Death  

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 patient has alleged nose irritation, respiratory tract irritation, lung disease, pulmonary fibrosis.The patient died.The device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: DREAMSTATION BIPAP PRO
• 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: 19002571
• MDR Text Key: 338880853
• Report Number: 2518422-2024-15859
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/28/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: DSX600H11
• Device Catalogue Number: DSX600H11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2015
• 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): Death; Other