MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problem Nodule (4551)

Event Date 01/01/2008

Event Type  Injury  

Event Description

A reporter called to submit a report about her herself and her husband's adverse effects they have experienced using cpap machine.She said they have been using the cpap device since 2008.She said they have a card accident in 2017 and went to the emergency room.She said when she has an x-ray performed to determine if she has broken bones, they found that she had nodules in her lungs.She was told to follow up with her primary doctor and she did.She said her doctor told her that the nodules are small, but they told her that they will watch it.She said she has used 3 different devices from 2008 to present.Her first device was changed to pro-line cpap on (b)(6) 2022.Then that machine has been recalled and she was given an interim device on (b)(6) 2023.That device has been recalled and replaced with the one she currently uses.She said she is happy with the one she has right now, but she is not using it often because of all the complaints she hears out there.Ref report: mw5154335, mw5154336.

• Brand Name: REMSTAR PRO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 19192516
• MDR Text Key: 341284322
• Report Number: MW5154337
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2024
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Race: White