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

Model Number UDSX500S11F

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pulmonary Dysfunction (2019); Dizziness (2194); Cardiovascular Insufficiency (4445); Unspecified Respiratory Problem (4464)

Event Date 01/04/2024

Event Type  Injury  

Manufacturer Narrative

H10: g: contact phone: (b)(6).H3 other text : device was not returned to the manufacturer.

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; nose irritation, respiratory tract irritation, dizziness and/or headache, hypersensitivity, asthma (new or worsening), inflammatory response, lung disease, reduced cardiopulmonary reserve other lung damage.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be carried out.If any additional information is received, a follow-up report will be filed.

• 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: 19125431
• MDR Text Key: 340388652
• Report Number: 2518422-2024-20293
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• 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
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• 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: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2019
• 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
• Patient Outcome(s): Other