MAUDE Adverse Event Report: RESMED CORP. RESMED CPAP AIR SENSE 10; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Bruise/Contusion (1754); Inflammation (1932); Pain (1994); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 09/27/2020

Event Type  Injury  

Event Description

Resmed engineer confirmed this things happened to people using their product too.Per clinical opinion, soft tissue swelling or inflammation is damage or injury to the muscles, tendons and ligaments.It is commonly caused by either acute injury (direct trauma) or overuse/excessive injuries of the involved tissue.Symptoms include pain, swelling and bruising.Treatment plans consist of medicine (anti-inflammatory, pain killers, corticosteroids), physical therapy and also rest.Under intended operating conditions of the device, it is not likely that the device and/or pap therapy had caused or contributed to the patient's symptoms as there are no direct skin contact between the device and the patient's face, neck or back area.The airsense 10 user guide provides the following warning: - "patients should report unusual chest pain, severe headache, or increased breathlessness to their prescribing physician.An acute upper respiratory tract infection may require temporary discontinuation of treatment".The safety risk and occurrence rate were assessed for each complaint and do not warrant a recommendation to take any immediate corrective or containment actions.

• Brand Name: RESMED CPAP AIR SENSE 10
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 19013797
• MDR Text Key: 339119997
• Report Number: MW5153435
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/27/2024

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: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2024
• Patient Sequence Number: 1
• Treatment: ANTI DEPRESSION AND HIGH BLOOD PRESSURE
• Patient Outcome(s): Life Threatening; Hospitalization; Disability; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Asian