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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 Problems Circuit Failure (1089); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 06/14/2019
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator failed testing.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 system board was replaced to address the issue.The device's flow straightener was cleaned due to dust and dirt.
 
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Brand Name
TRILOGY 100
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15668
MDR Report Key8776587
MDR Text Key150578971
Report Number2518422-2019-01470
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1054096
Device Catalogue Number1054096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/04/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2016
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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