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

Model Number 1109581

Device Problem Power Problem (3010)

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

Event Date 10/28/2019

Event Type  malfunction  

Event 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.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: OMNILAB ADVANCED PLUS
• Type of Device: 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
• MDR Text Key: 336519143
• Report Number: 2518422-2024-10213
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 308092728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• 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
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1