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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS INC. TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS INC. TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1040000
Device Problem Computer Software Problem (1112)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/08/2020
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator's oxygen percentage could not be adjusted.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 software was reloaded to address the issue.
 
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Brand Name
TRILOGY 202
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 Key9636359
MDR Text Key176650246
Report Number2518422-2020-00221
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K093905
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1040000
Device Catalogue Number1040000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2015
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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