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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 R1054655TP
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2024
Event Type  malfunction  
Event Description
A ventilator was returned to the manufacturer for routine preventative maintenance.There was no allegation of device malfunction.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, a failure of the device's lcd screen was observed.The device¿s lcd display was replaced to address the issue.
 
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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
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key18959707
MDR Text Key338366419
Report Number2518422-2024-14867
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberR1054655TP
Device Catalogue NumberR1054655TP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2024
Initial Date Manufacturer Received 03/20/2024
Initial Date FDA Received03/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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