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

Model Number DSX500T11

Device Problem Nonstandard Device (1420)

Patient Problems Tinnitus (2103); Solid Tumour (4552)

Event Date 10/20/2021

Event Type  Injury  

Event Description

I used a philips dream station cpap device that was purchased in november 2019.I stopped using the device when it was recalled in june 2021.I purchased a new machine in june 2021.In about (b)(6) 2021, i noticed my tinnitus had gotten worse and i went in to get my hearing checked.In (b)(6) 2021 i visited with a ent.The dr.Sent me for an mri which came back that i had a lesion or tumor on my cerebellum.I have had two mri's and spinal tap, they are uncertain exactly what it is and no doctor has indicated that it was caused by the cpap device.I have seen two neurologists, the second felt it could be a low grade glioma but neither doctor has given me a final diagnosis.I am scheduled for another mri in december to see if the abnormality has changed.Reading the fda's website, i felt like there could be a correlation.I currently take no medications other than vitamins and have had no significant health issues up to this time.Lesion/tumor measures approximately 1.5x1.7 cm at the left inferior cerebellar peduncle.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 15300949
• MDR Text Key: 298832790
• Report Number: MW5111727
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022485
• UDI-Public: (01)00606959022485
• 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: 08/23/2022
• 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
• Device Model Number: DSX500T11
• Device Catalogue Number: DSX500T11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2022
• Patient Sequence Number: 1
• Treatment: MULTIVITAMIN; NOT CURRENTLY TAKING ANY PRESCRIPTION MEDICATION, USING A NEW PHILIPS DREAMSTATION 2 CPAP MACHINE
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White