MAUDE Adverse Event Report: RESMED CORP. HOSES FOR APNEA CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 37296

Device Problem Use of Device Problem (1670)

Patient Problems Cough (4457); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2023

Event Type  Injury  

Event Description

Cpap apnea hoses are toxic and emit harmful chemicals when used.I have used these hoses for 12 years and been very ill and did not realize that these hoses are toxic.Breathing problems and phlegm and coughing.My doctor gave me a environmental pollutant urine test and found several high dose toxic chemicals in my urine.These chemicals are 2-methylhippuratre, phenylglyoxylate, alpha-hydroxyisobutyrate.I notified resmed the manufacturer and seller of the hoses, they did not want to see the urine test or take action to correct the problem.Thousands of people using these hoses are being slowly poisoned with toxic fumes that use cpap machines.I have found one manufacture that does not use toxic chemicals, i used it, and all my breathing and coughing problems are gone; 90 degree heated cpap hose for air 10 cpap machine.

• Brand Name: HOSES FOR APNEA CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 16727940
• MDR Text Key: 313227535
• Report Number: MW5116562
• 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: 04/08/2023

1 Device was Involved in the Event

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: 37296
• Device Catalogue Number: 37296
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2023
• Patient Sequence Number: 1
• Treatment: FISH OIL; GLAUCOMA EYE DROPS; THYROID MEDICATION ; TURMERIC ; VITAMIN D, K, C
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 145 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White