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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1032802
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/03/2021
Type of Reportable Event Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer for routine preventative 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's keypad was found to be stuck.The device's keypad was replaced to address the issue.
 
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Brand Name
TRILOGY 200
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
MDR Report Key11364251
Report Number2518422-2021-00507
Device Sequence Number19855784
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
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/23/2021
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 Manufacturer01/18/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/03/2021
Initial Report FDA Received Date02/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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