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

Model Number	R1054260
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned to the manufacturer because, due to an allegation of internal battery error codes, it did not meet the acceptance criteria of the evaluation process.The complaint was confirmed during the device's evaluation at the manufacturer's service center.The internal battery needed to be replaced.The device was scrapped.

• Brand Name: TRILOGY
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20517597
• Report Number: 2518422-2024-102510
• Device Sequence Number: 7794056
• Product Code: CBK
• UDI-Device Identifier: 00606959026308
• UDI-Public: (01)00606959026308
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: R1054260
• Device Catalogue Number: R1054260
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2014
• 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