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 AUTO CPAP; 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 AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number EUX500S15
Medical Device Problem Code Degraded (1153)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/22/2021
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer received information alleging that a continuous positive airway pressure (cpap) device's sound abatement foam became degraded.There was no patient injury or harm reported.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DREAMSTATION AUTO CPAP
Common Device Name
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
MDR Report Key12602229
Report Number2518422-2021-04685
Device Sequence Number19880176
Product Code BZD
UDI-Device Identifier00606959027435
UDI-Public00606959027435
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K131982
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source consumer,foreign
Initial Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 10/08/2021
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
Operator of Device Lay User/Patient
Device Model NumberEUX500S15
Device Catalogue NumberEUX500S15
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/23/2021
Initial Report FDA Received Date10/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		RES 88058
Patient Sequence Number1
-
-