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 100; 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 100; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1054096
Device Problems Contamination (1120); High Readings (2459)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2020
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator was alarming for a check circuit alarm condition and the device's tidal volume delivery was increased.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's overhead blower filter was found to be contaminated with dust and was cleaned to address the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRILOGY 100
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin dr.
new kensington, PA 15068
7243349303
MDR Report Key10852572
MDR Text Key216645425
Report Number2518422-2020-02749
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959022744
UDI-Public00606959022744
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1054096
Device Catalogue Number1054096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2020
Date Manufacturer Received10/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-