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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY O2; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. TRILOGY O2; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1040004
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2024
Event Type  malfunction  
Event Description
A ventilator was returned to the manufacturer for routine preventative maintenance.There was no allegation of device malfunction.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, it was observed that the device's whole screen turns white, and the displayed contents were not viewable.The device¿s lcd display was replaced to address the issue.
 
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Brand Name
TRILOGY O2
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
melissa rosko
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key19202746
MDR Text Key341286608
Report Number2518422-2024-23340
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959025394
UDI-Public00606959025394
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K093905
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1040004
Device Catalogue Number1040004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2024
Date Manufacturer Received04/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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