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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 Increase in Pressure (1491); Failure to Recalibrate (1517)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2020
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator was delivering high pressure.There was no harm or injury reported.The device has yet to be evaluated by the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Manufacturer Narrative
The manufacturer had previously reported an allegation of a ventilator delivering high pressure.During the evaluation of the device at the manufacturer's service center, the device failed a step during testing.The device's sensor board needs to be 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 drive
murrysville PA 15668
MDR Report Key11141170
MDR Text Key225815959
Report Number2518422-2021-00057
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 company representative,foreig
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
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 Manufacturer12/13/2020
Date Manufacturer Received01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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