MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. BIPAP ASV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Device Emits Odor (1425)

Patient Problems Nasal Obstruction (2466); Sleep Dysfunction (2517)

Event Date 09/08/2022

Event Type  Injury  

Event Description

Reporter calling after experiencing problems after receiving her replacement bipap machine.She states her original bipap was recalled and that the replacement device was received on or about (b)(6) 2022, and she had health problems starting the very first night she used it.She reports that her nasal passages were clogged "before i even got to sleep" and that the device had a smell/odor that was "like a glue smell".She was awoken during the night due to an asthma exacerbation, and reports that this had never happened to her before, even with her previous machine.She went to her doctor who advised her not to use this new machine.Reporter states "i am so disappointed" because she has central sleep apnea due to a brain injury and really needs this device.She has performed her own research and has learned that the replacement device contains "silicone and voc's" (volatile organic compounds) and that this concerns her.She states she feels like she has a sinus infection and "i don't know who to contact" regarding the machine problems.She states that using the humidifier that is part of the device makes her symptoms "even worse".She reports not sleeping well since she cannot use her replacement machine.She states the device is correctly assembled and connected, she ensured it had new filters, and that she cleans the machine using warm distilled water."i don't use ozone" cleaners.

• Brand Name: BIPAP ASV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 15563141
• MDR Text Key: 301554643
• Report Number: MW5112501
• Device Sequence Number: 1
• Product Code: MNS
• 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: 10/06/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2022
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female