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

Model Number DSX700S11F

Device Problems Improper Flow or Infusion (2954); Unexpected Shutdown (4019)

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

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

Event Description

The manufacturer received information regarding a dreamstation auto bipap.The patient alleges the device shuts off in the middle of the night.The patient reported the latch on the humidifier is broken and the use of duct tape is needed to close the lid.Troubleshooting was performed with the patient at the time of the reporting of the complaint, and while performing the troubleshooting technique, the patient stated the air pressure was too much and felt like it was suffocating at the moment.The patient's device pressure settings are 12.0 - 17.0 cmh20.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.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: 18865705
• MDR Text Key: 337211596
• Report Number: 2518422-2024-12799
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1