MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE INC HC431 SILICONE SEAL MEDIUM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 400HC104

Device Problems Degraded (1153); Disconnection (1171); Leak/Splash (1354); Unsealed Device Packaging (1444); Product Quality Problem (1506); Material Protrusion/Extrusion (2979)

Patient Problem Sleep Dysfunction (2517)

Event Date 05/11/2021

Event Type  Injury  

Event Description

I have had difficulty sleeping the last two weeks after i replaced the cushion in my flex fit 431 sleep apnea interface.On (b)(6) 2021, i discovered that the interface was leaking, and cushion was coming off.I disconnected it and used a back up last night to sleep.This morning i examined the entire interface and tubing carefully to determine the origin of the leak.I found that the medium silicone seal part number 400hc104 had a protruding, thin film of silicone coming from the edge that meets the hard, clear plastic mask.This protruding silicon prevents the cushion from sealing property, but it is not immediately obvious, since the seal was compromised while i was asleep.I tried to peal off the protruding silicone, but then realized the entire edge of the cushion was bad.I tried to report this incident to the manufacturer but had difficulty in locating an email or avenue to report adverse events.The device is necessary for breathing, and sleep apnea is a suspected cause of sudden death while asleep.For folks that breathe normally, temporarily losing sleep is not a big deal.However, for a sleep apnea patient such as myself, a defect in equipment like this can be life threatening.Overall, it is an excellent product that works well.This is qa manufacturing defect.Please note the product picture does not reflect the full extend of the protruding film of silicone, since i attempted to peal it off to fix it.I believe the lot number was 2100814385 (b)(4) on 2019-07-09.Fda safety report id # (b)(4).

• Brand Name: HC431 SILICONE SEAL MEDIUM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE INC
• MDR Report Key: 11831470
• MDR Text Key: 251369264
• Report Number: MW5101368
• Device Sequence Number: 1
• Product Code: BZD
• 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: 05/12/2021

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
• Device Model Number: 400HC104
• Device Lot Number: 2100814385
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Weight: 113