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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 1054096
Device Problems Failure to Charge (1085); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  malfunction  
Event Description
A ventilator was returned to the manufacturer for service.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, "service required" codes were found in the ventilator's downloaded error log, and the tubing connecting the sensor board to the flow sensor assembly was found disconnected.The device's internal battery was replaced and the tubing was reconnected to address the issues.
 
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Brand Name
TRILOGY 100
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin dr.
new kensington, PA 15068
7243349303
MDR Report Key11284687
MDR Text Key230440728
Report Number2518422-2021-00222
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959022744
UDI-Public00606959022744
Combination Product (y/n)N
Reporter Country CodeCH
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 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1054096
Device Catalogue Number1054096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2021
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2018
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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