Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION CPAP PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RESPIRONICS, INC. DREAMSTATION CPAP PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number DSX400H11
Device Problem Degraded (1153)
Patient Problems Dyspnea (1816); Burning Sensation (2146); Sore Throat (2396); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/22/2022
Event Type  malfunction  
Manufacturer Narrative
Device has yet to be returned for evaluation.
 
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 nasal/throat irritation or soreness, breaking her face.There was no report of 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 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 nasal/throat irritation or soreness, breaking her face.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The manufacturer received new information alleged spleen in throat, burning sensation in nostrils, shortness of breath.In this report section g, h has been updated/ corrected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DREAMSTATION CPAP PRO
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 Key16052045
MDR Text Key306194505
Report Number2518422-2022-103245
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDSX400H11
Device Catalogue NumberDSX400H11
Was Device Available for Evaluation? No
Date Manufacturer Received02/27/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/31/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberRES 88058
Patient Sequence Number1
-
-