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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1054096
Device Problems Contamination (1120); High Readings (2459)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2020
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator was displaying high tidal volume levels.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's overhead blower filter was found to be contaminated.The filter was cleaned to address the issue.
 
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Brand Name
TRILOGY 100
Type of Device
VENTILATOR, 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
Manufacturer Contact
adam price
312 alvin dr.
new kensington, pa 
3349303
MDR Report Key10244317
MDR Text Key197945268
Report Number2518422-2020-01527
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/19/2020
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
Device Operator Health Professional
Device Model Number1054096
Device Catalogue Number1054096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2020
Initial Date Manufacturer Received 06/19/2020
Initial Date FDA Received07/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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