MAUDE Adverse Event Report: RESPIRONICS, INC. OMNILAB ADVANCED PLUS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number 1109581

Device Problem Increase in Pressure (1491)

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

Event Date 05/17/2022

Event Type  malfunction  

Event Description

The manufacturer received information regarding an omnilan advanced plus.The customer alleges the device seemed to blow harder than the setting the device was placed on when the patient began use of the device.The customer adjusted the pressure, then the device alarmed and displayed a vent inoperable message.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

• Brand Name: OMNILAB ADVANCED PLUS
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 18941747
• MDR Text Key: 338140204
• Report Number: 2518422-2024-14515
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959028791
• UDI-Public: 00606959028791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1109581
• Device Catalogue Number: 1109581
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1