MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY US

Model Number R1054655TP

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2024

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned to the manufacturer.

Event Description

The manufacturer received information alleging a ventilator's screen was black and remained black when buttons were pressed.The screensaver was set to 'off' and the airflow was being delivered as usual.An hour later the reported screen displayed when the power was turned off and then turned on again.There was no harm or injury reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A supplemental report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer received information alleging a ventilator's screen was black and remained black when buttons were pressed.The screensaver was set to 'off' and the airflow was being delivered as usual.An hour later the reported screen displayed when the power was turned off and then turned on again.There was no harm or injury reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A supplemental report will be submitted when the manufacturer's investigation is complete.During the evaluation of the device at the manufacturer's service center, the alleged malfunction was unable to be confirmed during operational checking.It is possible that the issue was caused by a temporal failure to the circuit board.The circuit board was replaced to resolve the issue.Additionally, repair test, alarm check, battery check, run in tests, and cleaning were performed.The unit operated properly.A supplemental final report will be filed.

• Brand Name: TRILOGY100 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY US
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19021386
• MDR Text Key: 339140152
• Report Number: 2518422-2024-16928
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: Lay User/Patient
• Device Model Number: R1054655TP
• Device Catalogue Number: R1054655TP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1