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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. TRILOGY EVO; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number IN2100X15B
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2024
Event Type  malfunction  
Manufacturer Narrative
Device not returned to manufacturer.
 
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 detachable battery was replaced to address the issue.Additionally, the 3-way solenoid valve and fio2 sensor cable were also replaced, which was not related to the issue.
 
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Brand Name
TRILOGY EVO
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 Key18797242
MDR Text Key336641885
Report Number2518422-2024-10302
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K181166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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 Received02/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIN2100X15B
Device Catalogue NumberIN2100X15B
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/19/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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