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

Model Number 1054097

Device Problem Battery Problem (2885)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information alleging a ventilator's internal battery is not charging and the handle is damaged.There was no harm or injury reported.No medical interventions were specified.During the evaluation of the device, the allegations were confirmed.The internal battery, handle and 43 micron filter were replaced to repair the device.The device subsequently passed all tests.

• Brand Name: TRILOGY100 VENTILATOR
• 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: jenn canada ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19152911
• MDR Text Key: 340725624
• Report Number: 2518422-2024-21260
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959022751
• UDI-Public: 00606959022751
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 1054097
• Device Catalogue Number: 1054097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1