MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900S11F

Device Problem Temperature Problem (3022)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

The manufacturer became aware of a dreamstation bipap autosv device with a complaint that a bubbled circle appears on the bottom of the humidifier.The patient also alleged a red light on the screen and that he is unable to change the tubing temperature, but the tube feels warm when connected, even when the device is not running.There was no report of patient harm or injury.The manufacture's investigation is ongoing.A follow up report will be submitted when the manufacture's investigation is complete.

Manufacturer Narrative

H3 other text : not returned to the manufacturer.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 18150361
• MDR Text Key: 328301258
• Report Number: 2518422-2023-30679
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX900S11F
• Device Catalogue Number: DSX900S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male