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

Model Number 1054260

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

Patient Problem Decreased Respiratory Rate (2485)

Event Date 12/22/2015

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator was alarming for a "circuit disconnect" condition, although the circuit was not disconnected.The patient's respiratory rate dropped to 7 breaths per minute.The patient was taken to the emergency room where she was admitted for pneumonia.The patient has since been discharged from the hospital.The patient was reportedly on the same ventilator for 24 hours prior to being discharged from the hospital and the device functioned without issue.The ventilator was returned to the manufacturer's service center for evaluation.The ventilator passed all testing and was found to operate and alarm, as designed.Although "high pip" and "patient disconnect" alarms were observed in the ventilator's downloaded error log on the date of the alleged event, no malfunction of the device was observed.

• 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: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 5379785
• MDR Text Key: 36394565
• Report Number: 2518422-2016-00316
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959015364
• UDI-Public: 606959015364
• 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: health professional,user faci
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2009
• 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
• Treatment: NEBULIZER
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR