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

Model Number DSX1030H11C

Device Problem Degraded (1153)

Patient Problems Dry Eye(s) (1814); Headache (1880); Respiratory Tract Infection (2420)

Event Date 12/08/2022

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 an issue related to a bipap device's sound abatement foam.The patient has alleged particles in device and airway, throat irritation, eye irritation, headaches, device has burning smell.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.

• Brand Name: DREAMSTATION BIPAP ST
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 15971207
• MDR Text Key: 306090983
• Report Number: 2518422-2022-101702
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045590
• UDI-Public: 00606959045590
• 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

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: DSX1030H11C
• Device Catalogue Number: DSX1030H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2017
• 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