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

Model Number CPAP DOM

Device Problems Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problem Anxiety (2328)

Event Date 02/09/2023

Event Type  Injury  

Event Description

Philips replaced my dreamstation cpap machine with a used much older cpap which arrived (b)(6) 2023.My original purchased dreamstation was in feb 2021 and was recalled late spring of 2021.My original machine was made july 2020.It has only ever been used by me for a few months.After waiting over 1 year for my replacement machine from the official philips recall, the one that came is used disinfected machine made mar 2018.It also is missing the water chamber etc but that's not the issue since they said you have one.But it could be an issue but i refuse to suffer more emotional and potential physical harm by even trying it to see if it fits or if the machine even delivers on a setting of 15, ie severe osa.How is it acceptable to send used old cpap machines to replace much newer manufactured machines that were only ever used by the original owner.I have searched all over philips website, entered my account numbers and the only message i get is send back my machine because philips fulfilled its obligation.Also i tried the philips provided phone numbers 800-345-6443 and 833-262-1871 to again only be told philips fulfilled their recall obligation.I am a retired nurse practitioner.I worked in nursing homes for (b)(6) all through covid until dec 2021.I was at great personal risk of death from covid as a person over 65, diabetic, hypertensive, and obese person.Besides the financial harm of an old machine going to have a short life span, i am suffering emotional distress, post covid healthcare worker anxiety, about being told i have no recourse but to put an old used cpap machine attached to me.I do not have the support of a dme company due to this machine was bought directly by me and new from cpap.Com.I have heard from dme companies that their patients are receiving new dreamstation2 machines.I don't know if the fda can help me but i feel as a retired nurse practitioner, ie advocate for others, i need to tell you what is happening to us patients that have no where to turn, no dme company to advocate for us.I am on medicare and do have an insurance provided machine, but for post healthcare covid worker recovery, i spend time between pa and time with family in fl which is why i purchased a second new cpap machine the dreamstation.My case # from philips when i signed up for the recall: (b)(6) the serial number on my machine(b)(4), manufactured 2020-07-29.The replacement used dreamstation sent by philips serial no is (b)(4), manufactured 2018-03-30.My name is (b)(6).I appreciate any help the fda can provide.Anxious response and emotional distress from receiving the identified cpap used machine from philips as an acceptable replacement for my recalled dreamstation.My distress is intensified due to having worked full time through covid as an elderly aged np in the nursing homes witnessing my patients die from respiratory disease covid.I still have an active pa crnp license and left nursing home employment dec 2021.Cpap machine but not the dreamstation.Use every night with setting of 15.Not using the recalled machine due to it's recalled due to may cause medical harm, and too distressed to put in use an old refurbished used machine sent by philips as an acceptable recall replacement.

• Brand Name: CPAP DREAMSTATION AUTO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16386748
• MDR Text Key: 309775580
• Report Number: MW5114994
• 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: 02/13/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/09/2023
• Device Model Number: CPAP DOM
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CPAP ; CRESTOR; LEVOTHYROXINE ; METFORMIN ; MULTIVITAMIN; OLMESARTAN; RYBELSUS; TRIAMTERENE/HCTZ ; VASCEPA
• Patient Outcome(s): Disability
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White