MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV H/C, DS

Model Number DSX900H11C

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Headache (1880); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.Patient stated that he is coughing more often than normal.Headache, respiratory tract irritation, chest pressure, sinus infection.All of the information he stated that is due to him using his affected device.Unit is scrapped.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the manufacturer's quality product investigation laboratory for further investigation, in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.An internal investigation was performed on the device.The technician confirmed no particles in the air path or no visible foam degradation during the device evaluation.Device not needed for internal stock and will be scrapped per fc:16-700-623.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: DREAMSTATION BIPAP AUTOSV H/C, DS
• Type of Device: DREAMSTATION BIPAP AUTOSV H/C, DS
• 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: 17856489
• MDR Text Key: 324779524
• Report Number: 2518422-2023-25169
• 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
• Remedial Action: Recall
• 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: DSX900H11C
• Device Catalogue Number: DSX900H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1