MAUDE Adverse Event Report: RESMED CORP RESMED CPAP MASK AIRFIT F20 & AIR SENSE 10 AUTO SET; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 37035

Patient Problems Inflammation (1932); Pain (1994); Burning Sensation (2146); Discomfort (2330); Choking (2464); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 09/27/2020

Event Type  Injury  

Event Description

Uncomfortable masks and now resmed most masks were and are on recalled.Air blow out from resmed cpap (continuous positive airway pressure) air sense 10 auto set with heated humified machines.Choking to death and suffering and still suffering soft tissue swelling all over the body with inflammation all over the joints.Resmed inc.Push away all these serious harms to death for years.Very irresponsible resmed inc organizations and very abusive organization.Don't care only care about their own profits.Burning pains and damages organs including muscles, nerves, tendons and alignments, swelling face, chins, neck, fingers, feet and legs.

• Brand Name: RESMED CPAP MASK AIRFIT F20 & AIR SENSE 10 AUTO SET
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 19070584
• MDR Text Key: 339856375
• Report Number: MW5153650
• 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: 04/04/2024

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 Model Number: 37035
• Device Lot Number: 1411908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2024
• Patient Sequence Number: 1
• Treatment: ANTI-DEPRESSION.; MULTIVITAMINS.
• Patient Outcome(s): Life Threatening; Hospitalization; Disability; Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: Asian