FDA Adverse Event Injury Summary report: N

RESVENT IBREEZE 20A

MDR report key: 16437398 · Received February 23, 2023

Report

Report Number
MW5115161
Event Type
Injury
Date Received
February 23, 2023
Date of Event
December 12, 2022
Report Date
February 18, 2023
Manufacturer
RESVENT MEDICAL TECHNOLOGY CO., LTD.
Product Code
QOR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OK, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I'VE BEEN USING HAND ME DOWN CPAP MACHINES FOR AROUND 25 YEARS. I WAS ABLE TO GET A SLEEP STUDY AND NEW CPAP AT THE END OF 2022, A RESVENT IBREEZE 20A. I HAD A HARD TIME FALLING TO SLEEP DURING THE STUDY SO THE DOCTOR, (B)(6), HAD VERY LITTLE DATA TO DETERMINE MY CPAP SETTINGS. BY THIS TIME MY PREVIOUS CPAP MACHINE WAS SHOWING SIGNS OF WEARING OUT. THE NEW MACHINE OBSTRUCTED MY BREATHING FROM THE FIRST NIGHT. I WOKE UP EVERY MORNING EXHAUSTED. SOME NIGHTS I HAD TO GET UP EARLY BECAUSE I WOULD BE TOO OUT OF BREATH AND FEELING BAD TO SLEEP ANY LONGER. I HAD HOPED THE AUTO CPAP WOULD EVENTUALLY FIGURE OUT WHAT SETTINGS I NEEDED BUT IT NEVER CHANGED. ON (B)(6) 2022 I UPLOAD THE CPAP DATE, NOTIFIED THE DOCTOR, AND WENT BACK TO USING MY OLD MACHINE. THE TWO MOST PROMINENT PROBLEMS WERE RESISTANCE TO INHALING AND ONLY ALLOWING EXHALING IN SHORT BURST. HOWEVER THE DATA UPLOAD CLAIMED I WAS DOING WELL DESPITE HOW I WAS FEELING. ON (B)(6) 2023, THE DOCTOR HAD ME BRING IN BOTH THE OLD AND NEW CPAP. HE CHANGED SETTINGS IN THE NEW MACHINE TO REFLECT THE OLD ONE. THIS FIXED THE PROBLEM WITH EXHALING BUT THE INHALING RESISTANCE REMAINED. I USED THE NEW CPAP, SO I COULD GATHER DATA, UPLOADED ON (B)(6) 2023 AND WENT BACK TO USING MY OLD CPAP WHICH ONLY LASTED ANOTHER COUPLE OF DAYS. ON (B)(6) 2023 I HAD A SECOND SLEEP STUDY, THIS TIME WITH A CPAP, TO DETERMINE THE BEST SETTINGS FOR ME. I FOUND BREATHING MUCH EASIER AND MORE RELAXED DURING THIS SLEEP STUDY. THE CPAP SUPPLIER, OXYGEN OF OKLAHOMA HAD ME COME IN ON (B)(6) (I THINK) TO CHANGE THE CPAP SETTINGS TO WHAT WAS RECOMMENDED FROM THE SLEEP STUDY. THE TECH HAD ME PUT ON MY MASK AND TEST THE MACHINE AT THE OFFICE AND I FOUND INHALING TO BE EVEN MORE DIFFICULT. SHE CONTACTED MY DOCTOR AND HE DECIDED TO REVERT BACK TO THE PREVIOUS SETTINGS. THE TECH MADE A COUPLE OF OTHER CHANGES AND I AGREED TO USE THE MACHINE FOR ANOTHER WEEK AND UPLOAD THE DATA AGAIN. AROUND (B)(6), MY MOTHER, WHO WAS WORRIED ABOUT MY HEALTH, DECIDED TO GIVE ME MONEY TO BUY MY OWN CPAP MACHINE. I FOUND A REFURBISHED RESMED MACHINE, SAME AS MY PREVIOUS ONE, GOT A PRESCRIPTION FROM MY DOCTOR WITH THE SETTINGS FROM THE LAST SLEEP STUDY AND ORDERED ANOTHER CPAP MACHINE. ON (B)(6) 2023, I UPLOAD THE CPAP DATA, CALLED THE SUPPLIER AND LET HER KNOW I STILL COULD NOT INHALE PROPERLY WHILE USING THE MACHINE AND AM STILL WAKING UP EXHAUSTED EVERY MORNING. I LET HER KNOW I WAS SURE THE MACHINE IS DEFECTIVE AND I WANTED THE COMPANY TO REPLACE IT. SHE DIDN'T THINK THEY WOULD SINCE THE MACHINE'S REPORTS STATED EVERYTHING WORKED FINE. THE DOCTOR CALLED ME AFTER THEY RECEIVED THE UPLOADED DATA AND I TOLD THEM THE SAME. THEY ARE GOING TO CONTACT ME AGAIN MONDAY. DURING THE AFTERNOON OF (B)(6) 2023 THE RESMED CPAP ARRIVED. I IMMEDIATELY SET IT UP AND TESTED AND COULD BREATH MUCH EASIER AND MORE RELAXED. I USED THE RESMED WHILE SLEEPING LAST NIGHT AND I FEEL BETTER TODAY THAN I HAVE SINCE THIS ALL STARTED. I POSTED IN A FORUM WITH OTHER CPAP USERS AND SAW SOME OTHERS ARE ALSO NOT HAPPY WITH THE RESVENT IBREEZE MACHINES, ALTHOUGH I HAVE FOUND NO OTHER REPORTS OF ANYONE EXPERIENCING RESISTANCE TO INHALING LIKE I DID. I AM NOT SURE IF ONLY MY RESVENT MACHINE IS DEFECTIVE OR IF THEY ARE ALL THE SAME. I'M ALSO NOT SURE IF THE SUPPLIER WILL EXCHANGE THE ONE I HAVE OR NOT. I THOUGHT I SHOULD REPORT THIS MACHINE IN CASE IT DOES TURN OUT TO BE MORE THAN A SINGLE ISSUE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
856575 RESVENT IBREEZE 20A CONTINUOUS VENTILATOR, MINIMAL VENTILATORY SUPPORT QOR RESVENT MEDICAL TECHNOLOGY CO., LTD. IBREEZE 20A

Patients

Seq Age Sex Outcome Treatment
1 56 YR Male Other ADDERALL.| FLUTICASONE. | KRATOM.| LORATADINE.| PROPIONATE.| SINGULAIR.