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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 Failure to Recalibrate (1517); Tidal Volume Fluctuations (1634)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2020
Event Type  malfunction  
Event Description
During a check-out procedure at the manufacturer's service center, a ventilator failed to deliver the set tidal volume and failed a test step.The device was not in patient use.The device's sensor board needs 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
Manufacturer (Section G)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin dr
new kensington, PA 15068
7243349303
MDR Report Key10969692
MDR Text Key220471956
Report Number2518422-2020-02946
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959025387
UDI-Public00606959025387
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 company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
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 Manufacturer11/18/2020
Date Manufacturer Received11/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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