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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS INC. TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE

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RESPIRONICS INC. TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number DS2110X11B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Insufficient Information (4580)
Event Date 04/05/2021
Event Type  Death  
Event Description

The manufacturer received information alleging a patient expired while using a ventilator. The manufacturer is currently investigating this event and a follow-up report will be filed when the investigation is complete.

 
Manufacturer Narrative

It was initially reported, the manufacturer received information alleging a patient expired while using a ventilator. Repeated attempts for additional information or to have the device returned for evaluation and investigation were unsuccessful. The manufacturer believes they will be unable to gather additional information. The manufacturer is submitting a final report at this time. If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

 
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Brand NameTRILOGY EVO
Type of DeviceVENTILATOR, 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 drive
new kensington, PA 15668
MDR Report Key11251768
MDR Text Key229354832
Report Number2518422-2021-00261
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK181166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/08/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDS2110X11B
Device Catalogue NumberDS2110X11B
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/17/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/29/2021 Patient Sequence Number: 1
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