MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. ESON NASAL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 400450

Device Problem Nonstandard Device (1420)

Patient Problems Bacterial Infection (1735); Headache (1880); Visual Disturbances (2140); Sore Throat (2396); Eye Pain (4467); Unspecified Eye / Vision Problem (4471); Unspecified Ear or Labyrinth Problem (4474); Eczema (4547); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Pt states that this is her 3rd cpap machine for sleep apnea and that over the last several years she began having worsening immune system responses.Pt reports that she was dx with psoriasis early this year and eczema 2 years ago, has fluid buildup that has led to ear infections and required tube placement for drainage, headaches, throat irritation, eye irritation and swelling, flashes of light and 1 day ago seeing bursts of colors.Pt notes that she was seen at will eye hospital and had tests done with non remarkable findings for the cause of the burst of colors.Pt also notes black residue in the exhalation filter of the nasal mask after 2-3 days of usage.Pt is concerned about the origin of the black residue because the tubing of the cpap and the external filter are clean and she denies sneezing or coughing up black particles.Of note, pt states that her medical supply company contacted her to register her device with respironics and after registration was notified of a device recall with listed adverse events similar to what she is experiencing now.Pt states that she spoke with the she has contacted the manufacturer of the nasal mask in regards to the black residue she has noted on the exhalation filter and alleges that they told her there is nothing to worry about.Pt also notes that despite filing a report with the company about the mask issue, they have informed her they have no such record on file.Pt states that on (b)(6) 2021 she spoke with a representative of fisher, (b)(4) at (b)(4) who instructed the pt to email a picture of the dirty filter diffuser to this email: (b)(4), to which she did on (b)(6) 2021 and has yet to receive further correspondence.Pt states she is concerned about her worsening health despite following correct healthcare and wants to know if the black residue is coming from her lungs or the inside the cpap.Pt states that she is not expected to receive another cpap for about a year following the recall and is concerned with the lack of follow up she has received in regards to her device issues.

• Brand Name: ESON NASAL MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.
• MDR Report Key: 12908698
• MDR Text Key: 281612290
• Report Number: MW5105690
• Device Sequence Number: 2
• 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: 11/30/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 400450
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female