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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY O2; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC TRILOGY O2; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1040004
Device Problem Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/10/2018
Event Type  malfunction  
Event Description
The manufacturer received information alleging an issue with the oxygen delivery system.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the customer's complaint was confirmed.The device's interface board was replaced to address the issue.
 
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Brand Name
TRILOGY O2
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 Key7658905
MDR Text Key113034788
Report Number2518422-2018-01517
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K093905
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1040004
Device Catalogue Number1040004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/10/2018
Initial Date FDA Received07/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2017
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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