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. DREAMST; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
  • 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. DREAMST; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING Back to Search Results
Model Number GBX1030H20
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 02/22/2024
Event Type  Death  
Event Description
The manufacturer received information alleging an issue related to a dreamst device's sound abatement foam.The patient has sadly pass away.There was report of patient death.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Manufacturer Narrative
H3 other text : device not returned to manufacturer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DREAMST
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 Key18954147
MDR Text Key338301870
Report Number2518422-2024-14788
Device Sequence Number1
Product Code MNS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K102465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberGBX1030H20
Device Catalogue NumberGBX1030H20
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/20/2024
Initial Date FDA Received03/21/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/31/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
-
-