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

Model Number DSX1030T11C

Device Problem Degraded (1153)

Patient Problems Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457)

Event Date 02/02/2023

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.The manufacturer received information alleging sore throat, sinus infection, and nose irritation.There was no report of serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported receiving information in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no report of serious patient harm or injury.The manufacturer received additional information that the patient having cough and throat irritation.

• Brand Name: DREAMSTATION BIPAP ST
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 16305472
• MDR Text Key: 308868352
• Report Number: 2518422-2023-03893
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045606
• UDI-Public: 00606959045606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup

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: DSX1030T11C
• Device Catalogue Number: DSX1030T11C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/06/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1