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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200; THE DEVICE'S POWER SUPPLY WAS REPLACED TO ADDRESS THE ISSUE.
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RESPIRONICS, INC. TRILOGY 200; THE DEVICE'S POWER SUPPLY WAS REPLACED TO ADDRESS THE ISSUE. Back to Search Results
Model Number 1032804
Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem Cognitive Changes (2551)
Event Date 07/10/2016
Event Type  Injury  
Event Description
The manufacturer received information alleging a ventilator inoperative condition occurred while the device was in use.The patient was taken to an intensive care unit where he recovered following a short admission and was discharged.The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's blower assembly was replaced to address the issue.
 
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Brand Name
TRILOGY 200
Type of Device
THE DEVICE'S POWER SUPPLY WAS REPLACED TO ADDRESS THE ISSUE.
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
wilfredo alvarez
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key5837328
MDR Text Key50868239
Report Number2518422-2016-03312
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K093416
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Health Professional
Type of Report Initial
Report Date 07/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1032804
Device Catalogue Number1032804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
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