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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. TRILOGY EVO; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number JP2110X16B
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2023
Event Type  malfunction  
Event Description
The manufacturer received information alleging a ventilator service required alarm related to the internal battery.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 system board and detachable battery were replaced to address the issue.The system board was evaluated by the manufacturer's product investigation laboratory (pil) and found the system board functioned as designed and operated without issue or error codes.
 
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Brand Name
TRILOGY EVO
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
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key18946183
MDR Text Key338210965
Report Number2518422-2024-14580
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K181166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberJP2110X16B
Device Catalogue NumberJP2110X16B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2023
Date Manufacturer Received09/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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