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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. TRILOGY 100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1054260B
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2024
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator did not meet the acceptance criteria due to critical errors 192 and 290.There was no harm or injury reported.No medical interventions were specified.During the evaluation of the device at the manufacturer's service center, the critical errors of 192 and 290 could not be confirmed.The evaluation determined the internal and detachable batteries would not charge.The customer requests no repairs be made to the device.The internal battery was replaced at no charge.The detachable battery will be replaced with it becomes available.The inlet air path assembly and removable air path foam were replaced per remediation.
 
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Brand Name
TRILOGY 100 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC.
6501 living place
pittsburgh PA 15208
Manufacturer (Section G)
RESPIRONICS, INC.
6501 living place
pittsburgh PA 15208
Manufacturer Contact
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key18750716
MDR Text Key335965071
Report Number2518422-2024-08882
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 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 Received02/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1054260B
Device Catalogue Number1054260B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2024
Date Manufacturer Received01/31/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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