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

Model Number R1054655TP

Device Problem Battery Problem (2885)

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

Event Date 03/06/2024

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.There was no harm or injury reported.No medical interventions were specified.The device has not 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 received information alleging a ventilator's internal battery is not charging.There was no harm or injury reported.No medical interventions were specified.During the evaluation of the device at the manufacturer's service center the allegation of the internal battery not charging was not confirmed.The main pca was preventively replaced.During testing the detachable battery charged to 86% then an error occurred.The detachable battery was then replaced.The device then passed all tests.

• Brand Name: TRILOGY100 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 18949535
• MDR Text Key: 338242648
• Report Number: 2518422-2024-14643
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959025387
• UDI-Public: 00606959025387
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R1054655TP
• Device Catalogue Number: R1054655TP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2017
• 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