MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EXHALATION CIRCUITS; BREATHING CIRCUIT, VENTILATOR, SINGLE USE

Model Number	CN652002
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Dyspnea (1816); Hypoxia (1918)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging on "(b)(6) 2024, the clinical department received type ii respiratory failure patients, monitoring the blood oxygen saturation of 85% at admission, and the clinician used the ventilator to provide respiratory support to the patient, monitoring the blood oxygen saturation of 98%: one hour later, the ventilator alarm and the monitor alarm low blood oxygen saturation, the patient's blood oxygen saturation decreased to 87% and gradually decreased, the patient's shortness of breath significantly increased, and the respiratory pipe pressure detector was found to be broken and leaking, resulting in the patient's blood oxygen saturation decreased to 87% and gradually decreased, and a new breathing pipe pressure detector was immediately replaced to adjust the oxygen pressure of the ventilator.After treatment, the patient's blood oxygen saturation increased to 98%, and her vital signs returned to stability".
Additional Manufacturer Narrative
H3 other text : the device has not yet returned to the manufacturer.

• Brand Name: TRILOGY EXHALATION CIRCUITS
• Common Device Name: BREATHING CIRCUIT, VENTILATOR, SINGLE 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 Key: 18924491
• Report Number: 2518422-2024-14185
• Device Sequence Number: 18482779
• Product Code: CBK
• UDI-Device Identifier: 30606959008855
• UDI-Public: 30606959008855
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Company Representative
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: CN652002
• Device Catalogue Number: CN652002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown