MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATION CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DREAMSTATION

Device Problems Nonstandard Device (1420); Patient Device Interaction Problem (4001)

Patient Problems Abnormal Blood Gases (1034); Apnea (1720); Cardiac Arrest (1762); Dyspnea (1816); Urinary Tract Infection (2120); Respiratory Failure (2484); Lethargy (2560)

Event Date 10/10/2021

Event Type  Death  

Event Description

My mother passed away from acute respiratory failure with hypercapnia, obstructive sleep apnea and cardiopulmonary arrest on (b)(6) 2021.She was admitted on (b)(6) 2021, suffering with extreme mental status changes and shortness of breath.They discovered a uti and admitted her to give her iv antibiotics.But on the (b)(6), she became lethargic and upon drawing blood gases, they discovered she was retaining co2 in her lungs and could not figure out why.They ended up placing her on a bipap to try and clear the co2, but her levels kept rising and they didn't know why.She passed away on the evening of (b)(6) 2021.On 11/21/2021, i received her mail from philips respironics on the recall of her bipap machine she had been using for the past few years.Her model was affected and it lists that there was off-gassing occurring and could cause respiratory tract, asthma and toxic carcinogenic affects with the machine.I find it very concerning that this recall happened just after she passed from respiratory failure with no known cause in the hospital, so i wanted to report what happened to her.I did report it to philips respironics online in their recall registration as well.Death certificate lists the acute respiratory failure with hypercapnia, obstructive sleep apnea and cardiopulmonary arrest on (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12877897
• MDR Text Key: 281322939
• Report Number: MW5105580
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 11/22/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2021
• Patient Sequence Number: 1
• Treatment: SHE IS DECEASED
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White