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

Model Number	ND2110X15B
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a damaged liquid crystal display screen had occurred on the device.They alleged the damage is visible when starting the ventilator and no text can be read.They alleged harm but did not specify the type of harm.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 a damaged liquid crystal display screen had occurred on the device.They alleged the damage is visible when starting the ventilator and no text can be read.They alleged harm but did not specify the type of harm.The ventilator was returned to the manufacturer's product investigation laboratory (pil) for evaluation and the customer's complaint was confirmed.The manufacturer's product investigation laboratory (pil) powered on the device and found the lcd display to be shattered and unreadable.The manufacturer's product investigation laboratory (pil) concludes that no further evaluation is required at this time.

• Brand Name: TRILOGY EVO
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19367093
• Report Number: 2518422-2024-30232
• Device Sequence Number: 14384446
• Product Code: CBK
• UDI-Device Identifier: 00606959055513
• UDI-Public: 00606959055513
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2024

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
• Operator of Device: Other
• Device Model Number: ND2110X15B
• Device Catalogue Number: ND2110X15B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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