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 1032800
Medical Device Problem Code Device Operational Issue (2914)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/25/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device has been evaluated but not yet repaired pending approval of the service estimate by the customer.
 
Event or Problem Description
The manufacturer received information alleging a ventilator would not work with an active circuit.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the internal tubing was observed by the technician to be disconnected from the sensor board.The tubing will be reconnected 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 Key6796974
Report Number2518422-2017-01837
Device Sequence Number129529
Product Code CBK
UDI-Device Identifier00606959022829
UDI-Public00606959022829
Combination Product (Y/N)N
Initial Reporter CountryCO
PMA/510(K) Number
K093416
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date (Section B) 07/25/2017
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 Number1032800
Device Catalogue Number1032800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2017
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/25/2017
Initial Report FDA Received Date08/16/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-