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

Model Number 1054655

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/10/2018

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator had a ventilator inoperative condition and patient's blood oxygen saturation decreased.The patient was placed on another device and recovered.The manufacturer is currently investigating this event and a follow-up report will be filed when the investigation is complete.

Manufacturer Narrative

It was initially reported a ventilator inoperative condition occurred and the patient's blood oxygen saturation decreased.The ventilator was returned to the manufacturer for evaluation.The customer's allegation was confirmed.The device's blower motor was replaced to address the issue.The device was contaminated internally with dirt/dust.

• 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: 7525249
• MDR Text Key: 108613783
• Report Number: 2518422-2018-01221
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2018

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?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: 1054655
• Device Catalogue Number: 1054655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/28/2018
• Supplement Dates FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2016
• 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: 27 YR