FDA Adverse Event Injury Summary report: N

RESVENT I-BREEZE 20A

MDR report key: 22142089 · Received June 4, 2025

Report

Report Number
MW5171075
Event Type
Injury
Date Received
June 4, 2025
Date of Event
March 3, 2025
Report Date
May 28, 2025
Manufacturer
RESVENT MEDICAL TECHNOLOGY CO., LTD.
Product Code
QOR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAVE A RESVENT CPAP MACHINE MODEL I- BREEZE 20A. ABOUT THE FIRST OF MARCH IT STOPPED WORKING CORRECTLY. AT TIMES IT GIVES SHORT, RAPID BREATHS OF AIR, OTHER TIMES IT WOULD BLOW MORE AIR THAN IT WAS SUPPOSED TO. I TRIED DIFFERENT SIZE MASK OVER THE PAST COUPLE OF MONTHS. I HAVE ANOTHER MACHINE THAT I HAVE, AND FINALLY I THOUGHT TO TRY IT. MY SLEEP HAS GONE BACK TO NORMAL WITH THE OTHER MACHINE. I DON'T KNOW WHAT HAPPENED THAT CAUSED IT TO HAYWIRE. I USE UAB SLEEP CENTER IN (B)(6), AFTER MESSAGING WITH THEM SEVERAL TIMES I WAS TOLD THEY HAVE HAD COMPLAINTS FROM OTHER PATIENTS ABOUT THE SHORT PULSING OF AIR. I DON'T KNOW IF YOU HAVE RECEIVED COMPLAINTS FROM OTHERS BUT IT TOOK ME A COUPLE OF MONTHS TO FIGURE OUT. MY APNEA EVENTS RANGED FROM THE TEENS TO THE 20S DURING THIS TIME AND MY QUALITY OF SLEEP SUFFERED. I WOULD STILL BE SUFFERING, HAD I NOT HAD ANOTHER MACHINE TO FALL BACK TO. THANK YOU (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
719160 RESVENT I-BREEZE 20A CONTINUOUS VENTILATOR, MINIMAL VENTILATORY SUPPORT QOR RESVENT MEDICAL TECHNOLOGY CO., LTD.

Patients

Seq Age Sex Outcome Treatment
1 78 YR Male ARTIFICIAL KNEE.| ASPIRIN| BENADRYL 81 MG.| CLONAZEPAM.| ELECTRIC WHEELCHAIR.| LAXATIVE.| MELOXICAM.| MIRAPEX. | NEURONTIN.| OXYCODONE.| PRAVASTATIN.| PROPRANOLOL.| PROVIGIL.| SENNOSIDES.| SODIUM. | VITAMIN A. | WELLBUTRIN XL.| ZANAFLEX.