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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS INC. TRILOGY EV300; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS INC. TRILOGY EV300; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number IN2200X15B
Device Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator had a flow sensor failure.The device was not in patient use.The ventilator was returned to a third party service center for evaluation and the customer's complaint was confirmed.The device's external flow sensor cable was replaced to address the issue.
 
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Brand Name
TRILOGY EV300
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
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
adam price
312 alvin drive
new kensington, PA 15668
MDR Report Key11576025
MDR Text Key242457911
Report Number2518422-2021-00850
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K181166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIN2200X15B
Device Catalogue NumberIN2200X15B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2020
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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