MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	RSL1054260
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the device did not meet the acceptance criteria of the evaluation process for the following conditions: critical errors (193, 290).Error 193 internal li-ion battery permanent failure.The internal battery is the final power source.Failure of the internal battery may impact therapy.There is no allegation of serious or permanent harm or injury.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device not returned to the manufacturer.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging the device did not meet the acceptance criteria of the evaluation process for the following conditions: critical errors (193, 290).Error 193 internal li-ion battery permanent failure.The internal battery is the final power source.Failure of the internal battery may impact therapy.There is no allegation of serious or permanent harm or injury.Additional information from repair evaluation: no repair performed due to the device not needed for inventory.The unit will be scrapped.

• Brand Name: TRILOGY 100
• Common Device Name: 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18334403
• Report Number: 2518422-2023-35658
• Device Sequence Number: 6739267
• Product Code: CBK
• UDI-Device Identifier: 00606959026322
• UDI-Public: 00606959026322
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RSL1054260
• Device Catalogue Number: RSL1054260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown