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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1054655
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Patient Involvement (2645)
Event Date 06/10/2018
Event Type  malfunction  
Event 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 failed a test step during testing.The device's active exhalation control module was replaced to address the issue.
 
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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 Key7658530
MDR Text Key113020120
Report Number2518422-2018-01501
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Service and Testing Personnel
Type of Report Initial
Report Date 06/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1054655
Device Catalogue Number1054655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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