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

Model Number	1109581
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a check ac power supply error occurred.There was no harm or injury reported.Per the customer they tried a different outlet after it has alarmed and it worked fine.The device did have ecg spikes, the impedance values were red and could have been the cause for the spikes in the heart rate causing the high values.The body position sensor was also causing incorrect readings.The customer indicated that they did not see sensors on the belts.They will check with outside sales to see if they were provided to them.If they have further problems they will call back.No further action is needed at this time.
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.

• 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: 18794169
• Report Number: 2518422-2024-10213
• Device Sequence Number: 15266030
• Product Code: MNS
• UDI-Device Identifier: 00606959028791
• UDI-Public: 00606959028791
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: 308092728
• 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: 1109581
• Device Catalogue Number: 1109581
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2013
• 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