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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 1054655
Device Problems Circuit Failure (1089); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Event Description
The manufacturer received information alleging a "service required" alarm condition occurred related to a ventilator's temperature.There was no harm or injury reported.The manufacturer received the device for evaluation and the customer's complaint was confirmed.The device's outlet flow path thermistor needs replaced to address the issue.
 
Manufacturer Narrative
The manufacturer previously reported a "service required" alarm condition occurred relating to a ventilator's temperature and the device's outlet flow path thermistor was replaced to address the issue.During additional evaluation of the device, an additional "service required" code was found in the ventilator's downloaded error log.The device's power management board was replaced to address the issue.
 
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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
MDR Report Key11358003
MDR Text Key232824861
Report Number2518422-2021-00486
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959025387
UDI-Public00606959025387
Combination Product (y/n)N
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1054655
Device Catalogue Number1054655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2021
Date Manufacturer Received03/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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