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

Model Number LD2110X23B

Device Problems Circuit Failure (1089); Battery Problem (2885)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device evaluated by third party service center.

Event Description

A ventilator was returned to a third-party service center for service.The device was not in patient use.During the evaluation of the device at third-party service center, a "soft power failure" code was found in the ventilator's downloaded error log.The device's system board and internal battery were replaced to address the issue.In addition of the above evaluation, an air foam inlet filter will be replaced due to preventive maintenance, which was not related to the malfunction/issue.

• Brand Name: GARBIN EVO
• 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: 18699458
• MDR Text Key: 335343218
• Report Number: 2518422-2024-07072
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• 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: Other
• Device Model Number: LD2110X23B
• Device Catalogue Number: LD2110X23B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1