• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. REMSTAR PRO (450P); VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS / RESPIRONICS, INC. REMSTAR PRO (450P); VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problem Nonstandard Device (1420)
Patient Problems Pain (1994); Scar Tissue (2060); Impaired Healing (2378); Respiratory Tract Infection (2420); Cancer (3262)
Event Date 12/18/2018
Event Type  Death  
Event Description
My father got much relief from his disrupted sleep due to sleep apnea after being prescribed sleep machines by dr.(b)(6), his sleep doctor practicing in (b)(6), ms.(b)(6) philips respironics machines he used for over 10 years were a part of the june 2021 recall.I only discovered this recall a few weeks ago when i came across an article about propublica and pittsburgh gazette's investigation.My dad died 2 months before this "voluntary" recall in june 2021.In (b)(6) 2020, when my dad was diagnosed with stage iv lung cancer, it didn't make sense to our family that my father, who took good care of his health, would be riddled with cancer in his lungs.At the end of 2018 and beginning of 2019, it started with an upper respiratory illness from which he couldn't seem to recover.He met with a pulmonologist, dr.(b)(6), in (b)(6) 2019 for a cat scan which showed infection and he was treated for respiratory infection which did not improve with treatment.After more testing, my father was advised to have a serious surgery, decortication, to remove the scar tissue from his lungs in (b)(6) 2019 performed by thoracic surgeon dr.(b)(6).Pain was increasing and he was not healing properly from the surgery.He continued to experience horrific chest pain and ruled out heart issues in (b)(6) 2019 by having a stress test which he passed.By (b)(6) 2019, my father was in unbearable pain and asked his thoracic surgeon to refer him to pain management.Dr.(b)(6) finally heard the plea that something was terribly wrong and ordered a biopsy in early (b)(6) 2020.In (b)(6), my father finally got an explanation for the excruciating pain, his lungs were riddled with cancer which had spread to his ribs.The results had come from the biopsy sent to the (b)(6) clinic.He began treatment and pain management with oncologist dr.(b)(6).He received chemotherapy in (b)(6) 2020 and continued several rounds with little success.He died in hospice on (b)(6), 2021.When my family and i recently discovered the genotoxicity involved in the foam that philips chose to use in both cpap machines that my dad inhaled for over 10 years, we were horrified.Philips knowingly endangered all their clients and put profit over people.Though we can now make sense of my father's cancer diagnosis, we are appalled at the negligence involved in philips decision-making.I can't believe that this was even a voluntary recall and not a mandatory recall.The fda should be doing more to stop the harm caused by philips and these machines they knowingly kept on the market as approved medical devices.They are still out there being sold on ebay and craigslist right now.It really does seem that ethics are lost and profit before people is the code of conduct.*we are in the process of getting my father's medical records in order to have tests and dates available.
 
Event Description
Additional information received on 11/09/2023 for mw5147946 to reference report: mw5147947.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REMSTAR PRO (450P)
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS / RESPIRONICS, INC.
MDR Report Key18099994
MDR Text Key327755976
Report NumberMW5147946
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 11/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Patient Sequence Number1
Treatment
ALLERGY MEDS; BASIC PAIN RELIEVERS; BLOOD PRESSURE MEDICINE; SLEEP APNEA MACHINE
Patient Outcome(s) Death;
Patient Age76 YR
Patient SexMale
Patient Weight86 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
-
-