FDA Adverse Event Other Summary report: N

LUNA G3 BPAP 25/30VT

MDR report key: 17728430 · Received September 11, 2023

Report

Report Number
MW5145521
Event Type
Other
Date Received
September 11, 2023
Report Date
August 19, 2023
Manufacturer
3B MEDICAL INC.
Product Code
BZD
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I AM GENERATING THIS LETTER TO YOUR ATTENTION PURSUANT TO AN ISSUE THAT I AM HAVING WITH (B)(4) CHANGING OUT MY BI-PAP DEVICE FOR ANOTHER BRAND. I WAS ORIGINALLY ISSUED A LUNA BI-PAP MACHINE IN (B)(6) 2023. THE MACHINE THAT WAS ORIGINALLY SENT TO ME DID NOT OPERATE BECAUSE (B)(4) SENT ME THE WRONG WATER RESERVOIR AND HOSE FOR THE UNIT. I HAD CONTACTED (B)(4) AND HAD TO LEAVE A MESSAGE. EVENTUALLY, SOMEONE FROM (B)(4) CONTACTED ME AND SUBSEQUENTLY SUPPLIED ME WITH A WORKING LUNA DEVICE AND PARTS. I WAS HAVING ISSUES WITH THE DEVICE CAUSING ME LABORED BREATHING AND THE RESERVOIR WAS NOT WORKING PROPERLY. THE WATER WOULD NOT DISPENSE, AND I WAS NOT GETTING ANY HUMIDIFICATION WHEN BREATHING AND MY TONGUE AND MOUTH WERE VERY DRY HALFWAY THROUGH THE NIGHT. I HAD FOLLOWED UP WITH MY PHYSICIAN WHO INDICATED TO ME THAT THE DEVICE I HAVE IS NOT THE PROPER MACHINE TO USE AND SHE HIGHLY RECOMMENDS THAT I CHANGE THE MACHINE AS SOON AS POSSIBLE. SHE MENTIONED THAT SHE WOULD SEND IN A PRESCRIPTION TO (B)(4) FOR A DIFFERENT BRAND OF BI-PAP-MACHINE. MY PHYSICIAN ALSO STATED THAT SHE COULD NOT AUTOMATICALLY DOWNLOAD THE SLEEP DATA OVER THE COMPUTER THAT SHE NEEDED TO MONITOR MY PROGRESS, LIKE THE OTHER BI-PAP BRANDS. SHE MENTIONED THAT I WOULD HAVE TO COME INTO HER OFFICE EACH TIME FOR HER TO DOWNLOAD THE DATA. I CONTACTED AND SPOKE WITH A MANAGER AT (B)(4) ABOUT CHANGING THE BI-PAP DEVICE BRAND. I WAS TOLD THAT SINCE I DID NOT CONTACT THE OFFICE WITHIN 30 DAYS, (B)(4) COULD NOT AND WILL NOT EXCHANGE THE MACHINE FOR A DIFFERENT BRAND. IT DID NOT MATTER THAT MY PHYSICIAN SUBMITTED A NEW PRESCRIPTION FOR ANOTHER BRAND. I HAD INFORMED THE MANAGER THAT THE 30-DAY RULE SHOULD NOT APPLY, SINCE (B)(4) ORIGINALLY SENT ME THE WRONG EQUIPMENT WITH THE ORIGINAL LUNA BI-PAP DEVICE. I WAS ALSO NEVER INFORMED ABOUT ANY 30- DAY LIMITATION OF CHANGING A BI-PAP MACHINE. I FIND THIS POLICY TO BE UNCONSCIONABLE AND POSSIBLY AN ACTIONABLE CASE IN COURT. I AM A DISABLED PERSON ON SOCIAL SECURITY DISABILITY. IF A PATIENT IS SUFFERING WITH THE CURRENT MEDICAL DEVICE AND THEIR DOCTOR RECOMMENDS AND REQUESTS A DIFFERENT DEVICE, THEN THE MEDICAL SUPPLY COMPANY SHOULD HONOR THE PROPER EQUIPMENT, ESPECIALLY FOR A DISABLED PERSON. WOULD YOU PLEASE INVESTIGATE THIS SITUATION AND HAVE (B)(4) EXCHANGE MY BI-PAP DEVICE FOR A DIFFERENT BRAND. IN THE MEANTIME, I WILL BE REACHING OUT TO MY INSURANCE COMPANY, THE (B)(6) DEPARTMENT OF CONSUMER AFFAIRS, THE FDA AND US DOJ CIVIL RIGHTS DIVISION (SINCE I AM ON MEDICAL DISABILITY) AND ADVISE THEM OF THE SITUATION. I WOULD STRONGLY SUGGEST THAT YOU CONTACT YOUR LEGAL COUNSEL ON THIS SITUATION SINCE YOU MAY BE IN VIOLATION OF ADA TITLE II. I CAN BE REACHED AT #(B)(6), SHOULD YOU WANT TO DISCUSS FURTHER. THANK YOU.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2062691 LUNA G3 BPAP 25/30VT VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD 3B MEDICAL INC.

Patients

Seq Age Sex Outcome Treatment
1 Unknown