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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1040007
Device Problem Circuit Failure (1089)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2021
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, a "service required" code was found in the ventilator's downloaded error log.The device's oxygen blending module board was replaced to address the issue.
 
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Brand Name
TRILOGY 202
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge drive
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge drive
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin drive
new kensignton, PA 15068
7243349303
MDR Report Key11736238
MDR Text Key247666490
Report Number2518422-2021-01152
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959005150
UDI-Public00606959005150
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093905
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1040007
Device Catalogue Number1040007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Date Manufacturer Received04/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2016
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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