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

Model Number DSX900S11F

Device Problem Insufficient Information (3190)

Patient Problem Dry Mouth (4485)

Event Date 12/20/2023

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to a repaired dreamstation bipap autosv.The manufacturer received information alleging dry mouth.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

• Brand Name: REP 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: 18545450
• MDR Text Key: 333271718
• Report Number: 2518422-2024-03543
• Device Sequence Number: 1
• Product Code: MNS
• 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: 01/19/2024
• 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: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1