MAUDE Adverse Event Report: RESPIRONICS, INC TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1032800

Device Problems Failure to Recalibrate (1517); Application Program Problem (2880); Therapeutic or Diagnostic Output Failure (3023); Ventilation Problem in Device Environment (3027)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2019

Event Type  malfunction  

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.The device has not yet been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported a ventilator was alarming for a ventilator inoperative alarm condition.The ventilator was returned to the manufacturer for evaluation and the customer's complaint was confirmed.The device's software was reloaded to address the issue.During the evaluation of the device at the manufacturer's service center, the device failed a test step during testing.The device's active exhalation control module was replaced to address the issue.

• Brand Name: TRILOGY 200
• 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: 8335589
• MDR Text Key: 136550938
• Report Number: 2518422-2019-00345
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959026452
• UDI-Public: 00606959026452
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K093416
• 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,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1032800
• Device Catalogue Number: 1032800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2017
• 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