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 200; 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 200; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1032802
Medical Device Problem Codes Computer Software Problem (1112); Unexpected Shutdown (4019)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/08/2019
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The manufacturer's investigation is currently on-going and a follow-up report will be filed when the investigation is complete.
 
Additional Manufacturer Narrative
It was initially reported, the manufacturer received information alleging a ventilator inoperative condition occurred.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 software was reloaded to address the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRILOGY 200
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS INC.
1001 murry ridge lane
murrysville PA 15668
MDR Report Key8495247
Report Number2518422-2019-00776
Device Sequence Number1063077
Product Code CBK
UDI-Device Identifier00606959022690
UDI-Public00606959022690
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K093416
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/17/2019
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
Operator of Device Health Professional
Device Model Number1032802
Device Catalogue Number1032802
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Initial Date Received by Manufacturer 03/11/2019
Supplement Date Received by Manufacturer04/17/2019
Initial Report FDA Received Date04/09/2019
Supplement Report FDA Received Date04/18/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-