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

Model Number UDSX900S11F

Device Problem Degraded (1153)

Patient Problems Aortic Valve Stenosis (1717); Bronchitis (1752); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464)

Event Date 09/11/2023

Event Type  Injury  

Event Description

The manufacturer received information from the patient alleging that the patient is suffering from respiratory tract irritation, hypersensitivity with inflammatory response.Also patient is experiencing lung disease with reduced cardiopulmonary reserve and other diseases like bronchiectasis, aortic valve stenosis.No medical intervention was specified.The manufacturer was made aware of this information through a representative of the customer.Due to potential litigation surrounding this case, no follow up can be performed at this time and also no further investigation can be performed.If any additional information is received a follow up report will be filed.

Manufacturer Narrative

H3 other text : device has not been yet 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: 18268915
• MDR Text Key: 329746648
• Report Number: 2518422-2023-33617
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UDSX900S11F
• Device Catalogue Number: UDSX900S11F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other