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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 No Display/Image (1183); Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Event Description
A ventilator was returned to a third-party service center for foam replacement per field action: c&r 2021-05/06.During the evaluation of the device at the third-party service center, there were no visible foam particles observed.However, the device has a broken display screen and failed a test step during final testing.The device was not repaired since it came only for foam remediation.The device is returning unrepaired.
 
Manufacturer Narrative
H3 other text : device was evaluated by third-party service center.
 
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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
jenn canada
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key19023205
MDR Text Key339161266
Report Number2518422-2024-16958
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959022744
UDI-Public00606959022744
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1054096
Device Catalogue Number1054096
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/01/2024
Initial Date FDA Received04/02/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/06/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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