MAUDE Adverse Event Report: APEX MEDICAL CORP. APEX XT FIT CPAP; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number 9S-006500

Device Problems Degraded (1153); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

I have an apex xt fit cpap machine.I found what looks like lint in the part of the machine that holds distilled water.Since the distilled water tank is sealed off from room air, i wonder if this machine is undergoing degradation of its insulation which is making its way into the water tank.Please note this is not a philips machine under recall, but i suspect it's a similar problem.Just wanted to notify you that this product may also have to be recalled.Fda safety report id# (b)(4).

• Brand Name: APEX XT FIT CPAP
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): APEX MEDICAL CORP.
• MDR Report Key: 13333780
• MDR Text Key: 284448051
• Report Number: MW5106887
• Device Sequence Number: 1
• Product Code: BTT
• 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: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9S-006500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2022
• Patient Sequence Number: 1
• Treatment: CELEBREX ; COENZ-Q; FISH OIL CAPSULES; MULTIVITAMINS; PROSCAR ; VITAMIN D
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 2 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White