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. TRILOGY100 VENTILATOR; 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. TRILOGY100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1054260
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  malfunction  
Event Description
A ventilator was returned to the manufacturer for routine preventive maintenance.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, the device has no power when turned on.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
TRILOGY100 VENTILATOR
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 Key18753391
MDR Text Key336327976
Report Number2518422-2024-08729
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,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
Date FDA Received02/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1054260
Device Catalogue Number1054260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2024
Date Manufacturer Received01/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-