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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
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/15/2018
Type of Reportable Event Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator 's display screen was damaged.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's display screen was damaged.There was no harm or injury reported.The ventilator was returned to the manufacturer's service center for evaluation and the customer's complaint was confirmed.The device had evidence of physical damage.The device's lcd screen needs 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 Key8154974
Report Number2518422-2018-02958
Device Sequence Number19423989
Product Code CBK
UDI-Device Identifier00606959026452
UDI-Public00606959026452
Combination Product (Y/N)N
Initial Reporter CountryCA
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 11/15/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Initial Date Received by Manufacturer 11/15/2018
Supplement Date Received by Manufacturer12/29/2018
Initial Report FDA Received Date12/12/2018
Supplement Report FDA Received Date12/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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