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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. TRILOGY 100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1054260B
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2024
Event Type  malfunction  
Event Description
The manufacturer received information alleging an internal battery alarm condition occurred on a trilogy 100 device.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, a "internal battery failure" code was found in the ventilator's downloaded error log.The device was scrapped.
 
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Brand Name
TRILOGY 100 VENTILATOR
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 Key19000391
MDR Text Key338913672
Report Number2518422-2024-16030
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00606959026353
UDI-Public00606959026353
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1054260B
Device Catalogue Number1054260B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2024
Date Manufacturer Received03/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/02/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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