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

Device Problem Nonstandard Device (1420)

Patient Problems Asthma (1726); Headache (1880); Unspecified Infection (1930); Anxiety (2328); Sleep Dysfunction (2517)

Event Date 02/11/2021

Event Type  malfunction  

Event Description

This is regards to the use of my 2 philips cpap machine.I am medically required to use but with the experience i'm about to summarize, i have difficulty sleeping and tremendous anxiety about using these same machines that may have caused these illnesses.Any assistance to help with philips providing a replacement would be very much appreciated.I have registered and informed them of my other medical issues and have not got any reasonable level of support.Multiple issues over last year; major surgery, diagnosis of asthma, diagnosis of migraine headaches.From (b)(6) 2020 - 2/2021 i had a chronic sinus infection.After multiple visits to my primary care and urgent care.I started treatment with a allergy/immunologist.I was referred by him to ent.Surgery was required.In the surgery it was discovered that one of the sinus cavity infections had spread to the bone.The bone widens to protect the brain and that required reduction of my bone.This was a harrowing experience and the recovery was terrible.In the 9 months of this process i was on antibiotics and steroids.This had negative impacts to me.There is too much medical history to document here.But you are welcome to reach out for further information.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS INC.
• MDR Report Key: 13500244
• MDR Text Key: 285525270
• Report Number: MW5107329
• 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: 02/06/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White