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. TRILOGY EVO O2; VENTILATOR, CONTINUOUS, FACILITY USE
  • 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. TRILOGY EVO O2; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number FX2100X15B
Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2024
Event Type  malfunction  
Event Description
The manufacturer received information alleging a trilogy evo o2 ventilator has a broken screen, and the display does not work.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.
 
Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRILOGY EVO O2
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
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 Key19003174
MDR Text Key338904657
Report Number2518422-2024-16093
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959061019
UDI-Public00606959061019
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K093905
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
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? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberFX2100X15B
Device Catalogue NumberFX2100X15B
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/26/2024
Initial Date FDA Received03/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/13/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-