BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX XT FIT CPAP

    MDR report key: 13333780 · Received January 21, 2022

    Report

    Report Number
    MW5106887
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    January 18, 2022
    Report Date
    January 19, 2022
    Manufacturer
    APEX MEDICAL CORP.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830244 APEX XT FIT CPAP HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT APEX MEDICAL CORP. 9S-006500

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male CELEBREX | COENZ-Q| FISH OIL CAPSULES| MULTIVITAMINS| PROSCAR | VITAMIN D