MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1030T11

Device Problem Degraded (1153)

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Dizziness (2194); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 09/11/2023

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 from the patient alleging eye irritation, nose irritation, skin irritation, respiratory tract irritation, dizziness, headache, hypersensitivity, inflammatory response and face/neck pain.Medical intervention was not specified.The manufacturer was made aware of this complaint through a representative of the customer.The device has not yet been returned to the manufacturer for evaluation and there is no contact information for the initial reporter to gain additional information on the device.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 not returned to the manufacturer.

• Brand Name: DREAMSTATION BIPAP ST30
• 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: 18388593
• MDR Text Key: 331336335
• Report Number: 2518422-2023-37189
• Device Sequence Number: 1
• Product Code: MNS
• 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: Other,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

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX1030T11
• Device Catalogue Number: DSX1030T11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1