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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 DS2200X11B
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Event Description
A ventilator was returned to a third party service center for evaluation.The device was not in patient use.During the evaluation of the device at the third party service center, the lcd was found to be physically damaged.The device's display needs to be 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 rd
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC
1001 murry ridge rd
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin dr.
new kensington, PA 15068
7243349303
MDR Report Key11744830
MDR Text Key247938727
Report Number2518422-2021-01233
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959052017
UDI-Public00606959052017
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDS2200X11B
Device Catalogue NumberDS2200X11B
Was Device Available for Evaluation? No
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/12/2020
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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