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

Model Number DNX500H11C

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Headache (1880); Nausea (1970); Pain (1994); Rash (2033); Dizziness (2194); Excessive Tear Production (2235); Sore Throat (2396); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464); Eye Infections (4466); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/13/2021

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.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged eye infection, dizziness, nausea, nasal/throat irritation or soreness, pain, watery eye, leaking fluids from ears, irritability, rash on arms and neck, chest pain, chest pressure, migraine, dry throat, sinus, dry skin.There was no report of serious or permanent 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

Device has yet to be returned for evaluation.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 15881996
• MDR Text Key: 305366394
• Report Number: 2518422-2022-100506
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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: DNX500H11C
• Device Catalogue Number: DNX500H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2019
• 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