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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. TRILOGY100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1054260
Device Problems Defective Alarm (1014); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2023
Event Type  malfunction  
Event Description
A ventilator returned to the manufacturer for service.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the nurse call failed testing.The customer requested no repairs to be done.The unit will be returned to the customer unrepaired.
 
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Brand Name
TRILOGY100 VENTILATOR
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 Key18326926
MDR Text Key330501437
Report Number2518422-2023-35560
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959015364
UDI-Public00606959015364
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 Other,Company Representative
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2023
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 Manufacturer12/11/2023
Date Manufacturer Received12/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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