FDA Adverse Event Injury Summary report: N

IBREEZE 20A

MDR report key: 16631564 · Received March 28, 2023

Report

Report Number
MW5116059
Event Type
Injury
Date Received
March 28, 2023
Date of Event
March 19, 2023
Report Date
March 26, 2023
Manufacturer
RESVENT MEDICAL TECHNOLOGY CO., LTD.
Product Code
QOR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

THE DATE ABOVE IS THE DATE THE PROBLEM BECAME DEFINED. VIA MEDICARE, I RENTED A CPAP MACHINE FROM ROTECH.COM ON (B)(6) 2023. I BEGAN TO SUFFER SERIOUS SINUS INFECTIONS. I'VE BEEN TO THE EMERGENCY ROOM TWICE AND MY INFECTIOUS DISEASE SPECIALIST. I AM ON MY 4TH ROUND OF ANTIBIOTICS. ON (B)(6) 2023, MY MACHINE STOPPED WORKING. I LOOKED UP THE ERROR CODE AND IT POINTED TO A BAD BLOWER. THEN I WONDERED, HOW DOES A BLOWER GO BAD ON A BRAND NEW MACHINE? THEN I LOOKED AT MY "MACHINE HOURS" AND IT SAID IT WAS AT OVER 1000. MY USAGE WAS ONLY JUST OVER 200 HOURS. THEY'D SENT ME A USED MACHINE. NOWHERE IN MY PAPERWORK DID IT SAY I WAS GETTING A USED MACHINE. I QUESTIONED ROTECH WHEN I GOT THE MACHINE THAT THE MANUFACTURER SAID IT HAD ALREADY BEEN REGISTERED AND THEY SAID THEY "REGISTERED IT FOR ME". I WOULD HAVE NEVER USED IT, KNOWING IT WAS USED BECAUSE I AM IMMUNE COMPROMISED. I COMPLAINED TO MEDICARE. THEY SAY ROTECH BILLED THE MACHINE AS NEW, BUT LIKELY IT WOULDN'T MAKE ANY DIFFERENCE BECAUSE THE RATE THEY PAY FOR USED OR NEW IS THE SAME. SO THIS IS WHY THE COMPANIES THAT RENT DON'T DISCLOSE THAT THEY ARE SENDING OUT USED MACHINES. AT THIS POINT, I AM LEFT WITHOUT A NEW WORKING MACHINE. MY PHYSICIAN HAS WRITTEN A NEW PRESCRIPTION FOR A MORE DURABLE MACHINE THAT MEETS MY NEEDS. BUT NOW I CAN'T FIND ANOTHER DME COMPANY TO TAKE OVER THE CONTRACT BECAUSE THE NEW COMPANY WOULD GET PAID FOR THREE MONTHS LESS IN PAYMENTS (IN 13 MONTHS, YOU WILL OWN THE MACHINE). SO, ROTECH IS SENDING OUT USED, UNPROPERLY SANITIZED EQUIPMENT WITHOUT INFORMING CONSUMERS. THE MACHINE IS DUE TO BE PICKED UP FROM ROTECH ON (B)(6) 2023. MY COMPLAINT IS MAINLY THAT CPAP MACHINES ARE ALLOWED TO BE RE-USED BY DME DISTRIBUTORS SIMPLY BECAUSE IN A NEW STATE IT HAD FDA APPROVAL. THERE IS NO QUALIFYING METHOD TO SANITIZE THESE MACHINES FROM THE INSIDE OUT. SO THEY SHOULD EITHER ONLY SELL NEW ONES, OR BE REQUIRED TO DISCLOSE THAT THEIR MACHINES ARE USED AND LET HEALTH CARE PROVIDERS SPECIFY IF THEY BELIEVE THEIR PATIENTS REQUIRE A NEW MACHINE. ADDITIONALLY, A MACHINE WITH 1000 HOURS ON IT SHOULDN'T BE BREAKING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
210130 IBREEZE 20A CONTINUOUS VENTILATOR, MINIMAL VENTILATORY SUPPORT QOR RESVENT MEDICAL TECHNOLOGY CO., LTD. 20A

Patients

Seq Age Sex Outcome Treatment
1 54 YR Female Other 1/2 LOW DOSE ASPRIN DAILY (APPROX 40MG)| BENADRYL, | BENTYL, | CELEBREX.| FIORCET,| I HAVE AN ADVANCED BIONICS COCHLEAR IMPLANT. | MEDICALS WEEKLY ARE 100K OF VITAMIN D. | MONUROL AND | OCCASIONAL MEDS ARE PHENGREN, | TRAMADOL, | ZYRTEK,