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

Model Number DSX700H11C

Device Problem Degraded (1153)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Respiratory Tract Infection (2420); Cardiovascular Insufficiency (4445); Unspecified Respiratory Problem (4464)

Event Date 09/18/2023

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 eye, nose, respiratory irritation, hypersensitivity, inflammatory response, and reduced cardiopulmonary reserve.No other clinical information or medical intervention was specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported information 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 eye, nose, respiratory irritation, hypersensitivity, inflammatory response, and reduced cardiopulmonary reserve.No other clinical information or medical intervention was specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.In the previous report, "product problem" was selected as the type of reported complaint."serious injury" should have been selected and has been corrected in 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: 18546009
• MDR Text Key: 333276758
• Report Number: 2518422-2024-03577
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• 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,Company Representative
• 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: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11C
• Device Catalogue Number: DSX700H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2017
• 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