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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 DE2100X13B
Medical Device Problem Code Computer Software Problem (1112)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/05/2021
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The patient was placed on another device without incident.It was initially reported, the device did not alarm when the ventilator inoperative condition occurred.Additional information was received that indicates the device did alarm at the time of the event.The ventilator was returned to the manufacturer for evaluation and the customer's complaint could not be duplicated.Review of the device's downloaded event logs indicated a ventilator inoperative condition did occur on (b)(6) 2021.The device's software was reloaded to address the issue.
 
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Brand Name
TRILOGY EVO
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS INC.
1001 murry ridge lane
murrysville PA 15668
MDR Report Key11446333
Report Number2518422-2021-00628
Device Sequence Number3117518
Product Code CBK
UDI-Device Identifier00606959054103
UDI-Public00606959054103
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K181166
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/09/2021
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
Operator of Device Health Professional
Device Model NumberDE2100X13B
Device Catalogue NumberDE2100X13B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/09/2021
Initial Report FDA Received Date03/09/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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