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

Model Number DSX700S11F

Device Problems Decrease in Pressure (1490); No Flow (2991); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

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 cpap device's sound abatement foam.The patient alleged that the device is not working, pressure fluctuation, patient has a trouble breathing as if he was not getting enough air, stop randomly, blowing inconsistent amount of air.There was no patients harm or injury.There was no medical intervention reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: 18395581
• MDR Text Key: 331385207
• Report Number: 2518422-2023-37803
• 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: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700S11F
• Device Catalogue Number: DSX700S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2021
• 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