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

Model Number 1054260

Device Problem Battery Problem (2885)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

A ventilator was returned to the manufacturer for service with allegation of missing feet and initial power up and unable to attach hours.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, an error code related to internal battery permanent failure was observed.The following complaint were confirmed, could not obtain unit information, would not read through toolbox.No repair was performed to the device.Device was scrapped.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: TRILOGY100
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18995753
• MDR Text Key: 338835487
• Report Number: 2518422-2024-15627
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959015364
• UDI-Public: 00606959015364
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1