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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. TRILOGY100; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1054096
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2024
Event Type  malfunction  
Manufacturer Narrative
H3 other text : third-party service center.
 
Event Description
A ventilator was returned to a third-party service center for service.The device was not in patient use.During the evaluation of the device at the third-party service center, the device was not turning on.The third-party service center's investigation is ongoing.A follow-up report will be submitted when the third-party service center's investigation is complete.
 
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Brand Name
TRILOGY100
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 Key19154135
MDR Text Key340847414
Report Number2518422-2024-21311
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959022744
UDI-Public00606959022744
Combination Product (y/n)N
Reporter Country CodeRO
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1054096
Device Catalogue Number1054096
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/15/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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