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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 Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2024
Event Type  malfunction  
Event Description
A ventilator was returned to a third-party service center for service.There was no harm or injury reported.During the evaluation of the device at third-party service center, a "service required" code was found in the ventilator's downloaded error log.The device's internal battery fully charged to address the issue.Additional findings not related to the malfunction/issue was a detachable battery error, rubber feet missing, handle, and o-rings need replacing on the device.
 
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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
melissa rosko
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key19197595
MDR Text Key341238190
Report Number2518422-2024-22984
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,Distributor
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 Received04/26/2024
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2024
Date Manufacturer Received04/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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