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

Model Number DSX600H11C

Device Problems Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Nausea (1970)

Event Date 03/12/2024

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 dreamstation bipap pro device's sound abatement foam.The patient has alleged chest pain and nausea.The patient also states that the pressure on his recalled device was too high.Medical intervention was not specified.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : not returned to manufacturer.

• Brand Name: DREAMSTATION BIPAP PRO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18904777
• MDR Text Key: 337673990
• Report Number: 2518422-2024-13882
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX600H11C
• Device Catalogue Number: DSX600H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2018
• 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