FDA Adverse Event Malfunction Summary report: N

BELLUSCURA X-PLOR

MDR report key: 19981327 · Received August 13, 2024

Report

Report Number
MW5158385
Event Type
Malfunction
Date Received
August 13, 2024
Date of Event
August 6, 2024
Report Date
August 9, 2024
Manufacturer
BELLUSCURA, LLC.
Product Code
CAW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TN, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

OXYGEN CONCENTRATOR (BELLUSCURA, X-PLOR) DOES NOT PROVIDE ADEQUATE OXYGEN SATURATION, CONCENTRATOR WAS PURCHASED NEW IN MARCH OF 2024. SINCE DAY ONE I KEEP GETTING ERROR MESSAGES NOTING THAT THE SIEVE BEDS NEED TO BE REPLACED AND THAT OXYGEN LEVEL ARE DANGEROUSLY LOW LESS THAN 80% RESULTING IN MY OXYGEN LEVELS TO DROP. AFTER CALLING BELLUSCURA CUSTOMER SERVICE ((B)(4)) AND THE WEEKS AFTER I RECEIVED IT AND THE FOLLOWING WEEKS I KEPT GETTING THE SAME RESULTS THAT I NEEDED TO REMOVE THE SIEVE BED CARTRIDGE AND REINSTALL TO RESET THE CONCENTRATOR, THIS WORK FOR A FEW DAYS AND THE. THE ERROR MESSAGE WOULD REAPPEAR NOW 4 MONTHS LATER I NOW AM GETTING THE ERROR MESSAGES EVERY TIME I USE THE MACHINE MAKING IT USELESS AND IT WON'T RESET. I CALLED BELLUSCURA (B)(6) 2024 TALKED TO (B)(4) AND ANOTHER CUSTOMER SERVICE REP AND THEY SAID TO REMOVE SIEVE BED AND REINSTALL I EXPLAINED THIS DOESN'T WORK SO THEY SAID THEY WOULD SEND OUT A NEW SIEVE BED CARTRIDGE AND IT SHOULD FIX THE PROBLEM. STILL WAITING FOUR DAYS LATER AND THEY HAVE YET TO SEND A NEW SIEVE BED. I HAVE HAD TO RELY ON AN OLD DISCONTINUED CONCENTRATOR THAT I HAVE TO GET TO DOCTOR APPOINTMENTS AS I AM REQUIRED TO HAVE SUPPLEMENTAL OXYGEN 24/7 AS A PATIENT. BELLUSCURA'S EQUIPMENT DESIGN SEEMS TO BE FAULTY AS THERE ARE OTHER PATIENTS THAT HAVE ALSO REPORTED PROBLEMS WITH THE SIEVE BED CARTRIDGES GOING BAD.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1640573 BELLUSCURA X-PLOR GENERATOR, OXYGEN, PORTABLE CAW BELLUSCURA, LLC. 00850029991007

Patients

Seq Age Sex Outcome Treatment
1 62 YR Male OXYGEN 24/7, 2LPM