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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 Problems Application Program Problem (2880); Insufficient Information (3190)
Patient Problem Cyanosis (1798)
Event Date 09/14/2020
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator alarmed for a "ventilator inoperative" alarm condition.The patient became cyanotic and required medical intervention while on a ventilator.There was no permanent harm or injury reported.The device has not yet been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Manufacturer Narrative
The manufacturer previously reported a ventilator was alarming for a "ventilator inoperative" alarm condition.The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The root cause was determined to be related to the devices software.The device was scrapped.
 
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Brand Name
TRILOGY EVO
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
MDR Report Key10650981
MDR Text Key210467605
Report Number2518422-2020-02375
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K181166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIN2100X15B
Device Catalogue NumberIN2100X15B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2021
Date Manufacturer Received02/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age1.5 YR
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