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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1032800
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event 08/17/2016
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator had a charging issue.There was no harm or injury reported.The device has yet to be returned to the manufacturer for evaluation.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.
 
Additional Manufacturer Narrative
The manufacturer previously reported a ventilator had a charging issue.The device was evaluated at a third party service center and the customer's complaint was confirmed.The device's internal battery was replaced to address the issue.
 
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Brand Name
TRILOGY 200
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC
1001 murry ridge lane
murrysville PA 15668
MDR Report Key5950009
Report Number2518422-2016-03805
Device Sequence Number672757
Product Code CBK
UDI-Device Identifier00606959022829
UDI-Public00606959022829
Combination Product (Y/N)N
Initial Reporter CountryMX
PMA/510(K) Number
K093416
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date (Section B) 08/17/2016
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 Number1032800
Device Catalogue Number1032800
Was Device Available for Evaluation? No
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 08/17/2016
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date09/14/2016
Supplement Report FDA Received Date01/25/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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