MAUDE Adverse Event Report: RESMED CORP RESMED 11 CLIMATELINEAIR 11; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Aspiration/Inhalation (1725); Headache (1880); Burning Sensation (2146); Sore Throat (2396); Cough (4457)

Event Date 03/04/2024

Event Type  Injury  

Event Description

I received replacement heated hose for my resmed 11 cpap (continuous positive airway pressure) machine from resmed (b)(4).When i attached the hose to my resmed 11 cpap (continuous positive airway pressure) machine a strong toxic odor was emitted from the resmed 11 replacement hose causing me to develop a sore throat, headache and burning lungs and induced coughing.I would like the fda to test my resmed 11 machine & hose to determine what toxic chemicals are being emitted from my resmed 11 machine & heated hose to prevent any further damage to my respiratory system from using this product.Resmed 11 cpap machine and related cpap machine supplies including resmed climatelineair 11 hose provided by (b)(4).Reference report: mw5152426.

• Brand Name: RESMED 11 CLIMATELINEAIR 11
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 18855972
• MDR Text Key: 337245882
• Report Number: MW5152425
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: OCASSIONAL MULTI-VITAMIN.; RESMED 11 CPAP MACHINE.
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 147 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White