BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESMED AIR FIT F30I FULL FACE CPAP HEADGEAR & MASK

    MDR report key: 15428028 · Received September 14, 2022

    Report

    Report Number
    MW5112048
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 1, 2022
    Report Date
    September 8, 2022
    Manufacturer
    RESMED PTY LTD
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM ON HOME HEALTH USING BIPAP FOR CENTRAL SLEEP APNEA AND OXYGEN DURING THE DAY. ON OR AROUND THE END OF (B)(6) 2022, I RECEIVED NEW BIPAP EQUIPMENT (AIRFIT F30I FULL FACE CPAP HEADGEAR AND 2 FACEMASKS) FROM SUTTER BIPAP RESUPPLY. I REPLACED MY OLD EQUIPMENT ON (B)(6) AND THREW AWAY OLD EQUIPMENT. THAT NIGHT I DISCOVERED MY HEADGEAR TO BE NOT WORKING. MY HUSBAND ATTEMPTED TO FIX THE DAMAGED HEADGEAR WITH TAPE. THE NEXT DAY AT 12:45, I CALLED FOR REPLACEMENT OF MALFUNCTIONING EQUIPMENT AND TO REPORT THAT I WAS ONLY SENT TWO OF THE NASAL PILLOW MASKS. NOT THE ALLOTTED 3 AS I USUALLY RECEIVE EVERY 90 DAYS. I HAVE CALLED REPEATEDLY AND HAVE BEEN TOLD TO PURCHASE THEM MYSELF. TODAY I WAS INFORMED THAT THE ISSUE HAS BEEN RESOLVED AS I WAS INSTRUCTED TO PURCHASE REPLACEMENT EQUIPMENT PRIVATE PAY. THIS IS BAD PRACTICE AND WOULD NOT BE HANDLED THIS WAY IN ANY OTHER INSTANCE. WHILE I'VE BEEN WAITING FOR A RESOLUTION, I HAVE TRIED TO USE OXYGEN, BUT IT DOESN'T WORK AS A RESPIRATOR AS BIPAP DOES. I HAVE HAD ONGOING HEADACHES AND DAYTIME SLEEPINESS. MY USUALLY ACTIVITIES AND AOLS ARE SUFFERING. I HAVEN'T HAD A GOOD NIGHT SLEEP SINCE (B)(6). NOR HAD MY HUSBAND AS HE HAS TO KEEP TAPE BY THE BED AND REPEATEDLY REPAIR THE MASK DUE TO THE MACHINE HUMIDITY AND HIGH PRESSURE. THIS SHOULD HAVE BEEN AN EASY FIX. I HAVE NEVER HAD A PROBLEM WITH MY EQUIPMENT OR SUTTER BIPAP RESUPPLY BEFORE. I AM PERMANENTLY DISABLED WITH AUTONOMIC FAILURE AND ON HOME HEALTH AND CANNOT AFFORD TO SPEND $100+ PRIVATE PAY TO REPLACE FAULTY EQUIPMENT THAT SHOULD HAVE BEEN REPLACED BY SUTTER BIPAP RESUPPLY. PLEASE HELP. I JUST NEED REPLACEMENTS. HOW MANY OTHER PEOPLE ARE BEING TREATED POORLY BY THIS COMPANY. RESMED - SUPPLIED BY (B)(4). FDA. SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2751273 RESMED AIR FIT F30I FULL FACE CPAP HEADGEAR & MASK VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other ALL CURRENT PRESCRIPTION MEDICATIONS AND MEDICAL DEVICES BEING USED: IMPLANTED CARDIAC PACEMAKER, IMPLANTED POWER PORT-A-CATH, OXYGEN CORTEF, FLORINEF, LEVOTHYROXINE, ASPIRIN.| ALL OVER-THE-COUNTER MEDICATIONS AND ANY VITAMINS: VITAMIN B12, CALCIUM, VITAMIN D.