MAUDE Adverse Event Report: RESMED LTD. AIRFIT N20; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Reaction (1733); Erythema (1840); Urticaria (2278)

Event Date 12/15/2019

Event Type  Injury  

Event Description

Started using cpap on 12/14.When i woke up on 12/15, i had a large, hot, red raised area on my face beside my nose, where the mask was.I washed the mask, then used it again on 12/15.When i woke on 12/16, that area had grown larger and i had another one on the other side of my face.I went to my pcp, and he said it was an allergic dermatitis, that they were hives that appear to be related to the mask.My only known allergy is to latex, but the masks are supposed to be latex free.Allergic dermatitis, hives.Fda safety report id # (b)(4).

• Brand Name: AIRFIT N20
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD.
• MDR Report Key: 9516194
• MDR Text Key: 172805223
• Report Number: MW5091860
• 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: 12/20/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 133