MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY O2; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1040004

Device Problem Use of Device Problem (1670)

Patient Problems Respiratory Distress (2045); Low Oxygen Saturation (2477)

Event Date 09/12/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient's blood oxygen saturation decreased and volume delivery decreased.The issue was found to be due to the device's air inlet port being blocked by a plastic bag being hung too close to the back of the device.The device alarmed for 30 minutes without intervention.The plastic bag was removed from the air inlet port and the patient's blood oxygen saturation and volume delivery returned to normal.

• Brand Name: TRILOGY O2
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge rd; murrysville PA 15668
• Manufacturer Contact: adam price ; 312 alvin dr.; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 9255902
• MDR Text Key: 164288828
• Report Number: 2518422-2019-02478
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1040004
• Device Catalogue Number: 1040004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 38