MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1054260

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hypoxia (1918); Blurred Vision (2137); Loss of Vision (2139)

Event Date 11/01/2016

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient lost vision in his right eye due to a lack of oxygen.He appears to have been using a ventilator with an oxygen bleed-in from a concentrator.The tubing from the concentrator appears to have become disconnected.The manufacturer's investigation is currently on-going and a follow up report will be filed when the investigation is complete.

Manufacturer Narrative

It was initially reported the manufacturer received information alleging a patient lost vision in his right eye due to a lack of oxygen.Repeated attempts for additional information and to have the device returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: TRILOGY 100
• 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: adam price ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 6337053
• MDR Text Key: 67613276
• Report Number: 2518422-2017-00448
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959026353
• UDI-Public: 00606959026353
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2016
• 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: 66 YR