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

Model Number UDSX500S11F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cancer (3262); Unspecified Respiratory Problem (4464)

Event Date 10/12/2023

Event Type  Injury  

Event Description

The manufacturer became aware of a rep dreamstation auto cpap device alleging symptoms of nose irritation, and cancer.Medical intervention was not specified by the patient.Due to potential litigation surrounding this case, no follow-up can be performed at this time.At this time, 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 returned to manufacturer.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19160102
• MDR Text Key: 340789861
• Report Number: 2518422-2024-21485
• 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: Other,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: 04/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UDSX500S11F
• Device Catalogue Number: UDSX500S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other