MAUDE Adverse Event Report: PHILIPS/RESPIRONICS INC. SYSTEM ONE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 10/01/2021

Event Type  Injury  

Event Description

Was having issues in 2021 with breathing problems and was having issues while using bipap at night.After visiting my doctor they suggest i get a new bipap, which i did at that time, which cost me over (b)(6).I then learned of the recall and filed for it and was given case number (b)(4).Since then i have contacted them three times giving my doctors information (b)(6) i got yet another email telling me if i haven't received my replacement to contact them again to give drs information.I called that day at 11:47am and had to leave information and message said they would call back within hours 48 hours.So for 48 hours i kept the case number in my pocket waiting for the call.Nothing.Today at 6:pm which was way more than the 48 hours.I was very upset and asked what happened to the three previous times i gave doctors information and what happened to my callback within 48 hours and they hung up because i didn't have the case number at hand.This is now going on well over two years since i filed the case with them and get a email each month telling me if you have not yet received your replacement give us a call.Here's my questions, dont they know who they have sent replacements to, if they were calling me due to my message which included name phone and case number, why did they need the case number again.It is my opinion that they are doing this deliberately to exasperate consumers to just give up so they dont have to replace something they knew was defective.It time to fine the heck out of them and not only send a message to them and to all other companies out there who sell defective products and then put people through the worst time so they hope they will give up.Please take action immediately with this company either to correct things now or put them out of business.

• Brand Name: SYSTEM ONE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 18192162
• MDR Text Key: 328957799
• Report Number: MW5148375
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ALBUTEROL ; ALBUTEROL SULFATE INHALER; ASPIRIN ; BENADRYL ; CARVEDILOL 3.125; EXETIMIBE 10 MG; IPRATROPIUM .06%; JARDIANCE 25MG; MELATONIN ; METFORMIN 1000MG; MOUNJARO; PLAVIX ; PRALUENT; VITAMIN D3
• Patient Outcome(s): Disability
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White