MAUDE Adverse Event Report: RESPIRONICS, INC. OMNILAB ADVANCED PLUS; PORTABLE ELECTRIC VENTILATOR

Model Number	1109582
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a ventilator inoperative condition occurred.There was no harm or injury reported.During the evaluation of the device at the manufacturer's service center, the customer complaint was confirmed.The devices pca and bottom enclosure were replaced and the firmware updated to v3.7.The device passes testing.

• Brand Name: OMNILAB ADVANCED PLUS
• Common Device Name: PORTABLE ELECTRIC VENTILATOR
• 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: 18810999
• Report Number: 2518422-2024-10755
• Device Sequence Number: 14279603
• Product Code: MNS
• UDI-Device Identifier: 00606959029415
• UDI-Public: 00606959029415
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K090248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial 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 Model Number: 1109582
• Device Catalogue Number: 1109582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown