MAUDE Adverse Event Report: RESMED PTY LTD RESMED AIR FIT F30I FULL FACE CPAP HEADGEAR & MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Product Quality Problem (1506); Defective Component (2292); Component Missing (2306)

Patient Problems Fatigue (1849); Headache (1880); Sleep Dysfunction (2517)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

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failure and on home health and cannot afford to spend $100+ private pay to replace faulty equipment that should have been replaced by sutter bipap resupply.Please help.I just need replacements.How many other people are being treated poorly by this company.Resmed - supplied by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).

• Brand Name: RESMED AIR FIT F30I FULL FACE CPAP HEADGEAR & MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD
• MDR Report Key: 15428028
• MDR Text Key: 300311980
• Report Number: MW5112048
• Device Sequence Number: 1
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: 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.
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White