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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 IN2100X15B
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Pneumonia (2011)
Event Date 07/22/2020
Event Type  Death  
Event Description

The manufacturer received information alleging a patient expired while the ventilator was in use. The patient was admitted for covid 19 pneumonia and was placed on the ventilator. The patient later expired after resuscitation efforts were unsuccessful. The device has not yet been returned to the manufacturer. At this time, we are unable to confirm a malfunction of the ventilator. A follow-up report will be submitted when the manufacturer's investigation is complete.

 
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Brand NameTRILOGY EVO
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge rd
murrysville, pa
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 Key10345099
MDR Text Key201033682
Report Number2518422-2020-01804
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK181166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIN2100X15B
Device Catalogue NumberIN2100X15B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/19/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/29/2020
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: 07/30/2020 Patient Sequence Number: 1
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