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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 1054096
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2018
Event Type  malfunction  
Event Description
A ventilator was returned to a third party service center for evaluation.There was no harm or injury reported.During the evaluation of the device at a third party service center, the device failed test steps during testing.The device's active exhalation control module was replaced to address the issues.
 
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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 Key7517960
MDR Text Key108371742
Report Number2518422-2018-01115
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959022744
UDI-Public00606959022744
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2015
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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