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

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Immunodeficiency (2156); Ambulation Difficulties (2544); Cancer (3262)

Event Date 05/31/2018

Event Type  Injury  

Event Description

Went to the hospital because i could not walk when i got up out of bed on (b)(6) 2018.Received a new philips dream station cpac (continous positive airway pressure) machine in (b)(6) 2016 and used daily.Was going to the doctors from (b)(6) 2018 when i was diagnosed with multiple myeloma cancer.I continued to used this machine during a stem cell transplant as i did not know there were any problems with this machine.I was not notified by philips or local distributor that this machine was recalled ( in june 2021).I discovered on my own thru illness in (b)(6) 2022 that my machine had been recalled.Philips could not tell me (actually refused to tell me) why i was not notified of the recall.I finally stopped using the machine the (b)(6) 2022.Philips replaced the cpac in (b)(6)of 2022 but i immediately had trouble with it.Philips told me it had been inspected and the new reissued machines were safe.I stopped using this machine and used an older machine that was not a philips.I had to wait until 2023 to get an appointment for a new prescription for a new cpac.I refused another philips.I have been on constant chemotherapy pills and infusions for 5 and half years.I think the dates are too coincidental not to be caused by this philips machine.The financial obligations of this cancer treatment has changed my life.I am in constant pain.There is no cure for multiple myeloma.This is not even mentioning the personal injury.Besides pain i can no longer do the things i did before.My wife retired to take care of me.I still work due to the high cost of the multiple myeloma drugs.I cannot afford to use all my savings to pay for these drugs.This is a short synopsis.The financial burden also includes time lost at work due to illness.Ongoing treatments, blood work costs, chemo ports insertion and removal.Hospital time due to infections.I can no longer enjoy life due to a compromised immune system i am sure i will have a shorter life span due to this cancer.I also had fractures in my spine due to the myeloma which makes walking painful.I do not have this information from 5 years ago.I am sure the hospital still has records from when i was diagnosed.I was diagnosed by blood tests, xrays and bone marrow biopsy tests.

• Brand Name: PHILIPS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 18704128
• MDR Text Key: 335461635
• Report Number: MW5151562
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: CALCUIM TABLETS; CHLORTHALIDONE DEXAMETHASONE ; MULTIVITAMINS ; POMALYST ; RESMED CPAC MACHINE KYPROLIS CHEMO ; TURMERIC CAPSULES ; VALACYCLOVIR XARELTO
• Patient Outcome(s): Disability; Hospitalization; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White