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

Model Number RIN2110X15B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dyspnea (1816)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : the device has yet to be returned to the manufacturer.

Event Description

The manufacturer received information alleging a patient experienced difficulty breathing.A nurse stated the "ventilation rate was around 90, but gradually decreased to 0.The leak remained around 20 while device seemed to be functional, and a circuit disconnect alarm frequently occurred.The nurse switched to resuscitation bag.Patient's level of consciousness improved.The patient was transported to the hospital.The previous day (b)(6) 2024) during a doctor's visit, the patient was given permission to drink water, and there are suspicions of obstruction caused by drinking water, but an investigation for the device was requested just in case.The patient recovered from the symptoms on (b)(6) 2024 has been switched to an evo home ventilator on the ward.He is currently undergoing treatment with a goal of being discharged again".The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported information alleging a patient experienced difficulty breathing.A nurse stated the "ventilation rate was around 90, but gradually decreased to 0.The leak remained around 20 while device seemed to be functional, and a circuit disconnect alarm frequently occurred.The nurse switched to resuscitation bag.Patient's level of consciousness improved.The patient was transported to the hospital.The previous day ((b)(6)2024) during a doctor's visit, the patient was given permission to drink water, and there are suspicions of obstruction caused by drinking water, but an investigation for the device was requested just in case.The patient recovered from the symptoms on (b)(6) 2024 and as of (b)(6) 2024 has been switched to an evo home ventilator on the ward.He is currently undergoing treatment with a goal of being discharged again".The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A supplemental report will be submitted when the manufacturer's investigation is complete.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was not confirmed.The device failed "fio2 sensor receptacle verification" for final test.Since the cause was found to be contamination on fio2 tubing, fio2 tubing was replaced to address the issue.

• Brand Name: TRILOGY EVO
• 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 Key: 18996375
• MDR Text Key: 338885810
• Report Number: 2518422-2024-15762
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RIN2110X15B
• Device Catalogue Number: RIN2110X15B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male