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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 1054260
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2024
Event Type  malfunction  
Event Description
A ventilator was returned to the manufacturer for foam remediation.There was no harm or injury reported.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, the device failed test steps during testing for the hw power fail test.The active exhalation control module was replaced to resolve this issue on the device.The internal/detachable battery was replaced on the device.Additional findings not related to the malfunction/issue include the screw beneath porting block was not seated, damage to the bottom on the front enclosure.The customer does not want any repairs done to the unit and it will be returned unrepaired.
 
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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
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key18691395
MDR Text Key335194001
Report Number2518422-2024-06969
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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 Received02/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1054260
Device Catalogue Number1054260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2024
Date Manufacturer Received01/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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