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

Model Number DSX700S11F

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Intermittent Loss of Power (4016)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer became aware that a user of the dreamstation auto bipap alleging device stopped working in the middle of night.Patient states, "device turning on and off on its own", device was not working intermittently" and showing and error message "sd card error.Please remove and reinsert." patient also alleges burning smell from device and device is overheating.Patient used soclean device.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: 18169652
• MDR Text Key: 328533594
• Report Number: 2518422-2023-30757
• 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: 10/30/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male