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. OMNILAB ADVANCED PLUS; 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. OMNILAB ADVANCED PLUS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING Back to Search Results
Model Number 1109581
Device Problem Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2023
Event Type  malfunction  
Manufacturer Narrative
H3 other text : device not returned to manufacturer.
 
Event Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OMNILAB ADVANCED PLUS
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 Key18866500
MDR Text Key337226413
Report Number2518422-2024-12842
Device Sequence Number1
Product Code MNS
UDI-Device Identifier00606959028791
UDI-Public00606959028791
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1109581
Device Catalogue Number1109581
Was Device Available for Evaluation? No
Date Manufacturer Received04/20/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/26/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-