FDA Adverse Event Injury Summary report: N

DREAM MACHINE 2 CPAP

MDR report key: 17773257 · Received September 18, 2023

Report

Report Number
MW5145821
Event Type
Injury
Date Received
September 18, 2023
Date of Event
September 4, 2023
Report Date
September 14, 2023
Manufacturer
PHILLIPS / RESPIRONICS INC.
Product Code
BZD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

MY HUSBAND JUST HAD HEART SURGERY AND HIS CPAP MACHINE STOPPED WORKING JUST AFTER WE CAME HOME FROM THE HOSPITAL, HENCE HIS RECOVERY IS VERY DIFFICULT BECAUSE PHILIPS HAS NOT SENT THE REQUESTED REPLACEMENT. IT IS HARD TO LISTEN TO MY HUSBAND STRUGGLE TO "BREATHE" WITHOUT THE CPAP MACHINE. IT'S HARD TO WATCH THE EXHAUSTION HE IS EXPERIENCING IN THIS RECOVERY PHASE BECAUSE HE CAN'T GET A MACHINE FROM PHILLIPS. TICKET NUMBER (B)(4). I'VE CALLED (AS REQUESTED) EVERY FEW DAYS AND AFTER MORE THAN TWO WEEKS I HEAR THE SAME RESPONSE - "IT'S IN PROCESS" AND PHILLIP'S STAFF HAS NO IDEA WHEN IT WILL BE SHIPPED. THEY GIVE NO REASON AND SAY THEY HAVE NO IDEA HOW LONG IT WILL TAKE TO BE PROCESSED. I GET PUT ON HOLD OR HUNG UP ON WHEN THEY ARE CALLING AROUND TO TRY TO FIND OUT. SEEMS LIKE THE DEPARTMENTS DO NOT WORK TOGETHER. I DON'T LEAVE A MESSAGE ANYMORE BECAUSE NO ONE CALLS BACK. TODAY, I JUST LEARNED FROM PHILLIP'S PATIENT SUPPORT THAT THE PROBLEM IS THAT THE DEPARTMENT THAT HAS THE SETTINGS HAS NOT FORWARDED THE INFORMATION TO THE PROCESSING DEPARTMENT. THAT"S THE HOLD UP. IT'S AN INTERNAL PROBLEM. PLEASE GET INVOLVED AND GET THESE BUSINESS PROCESSES IMPROVED. I ALSO JUST TALKED WITH THE PHILIPS RESPIRONICS TEAM AND THEY CONFIRMED THAT THERE IS NO APPEAL PROCESS OR MANAGEMENT THAT WILL TALK ABOUT IMPROVING THE PROCESS TIME OR GET AN EXPEDITED MACHINE EVEN DUE TO AN OPEN HEART AND BYPASS SURGERY. THIS GIVES US MANUFACTURING A VERY POOR NAME. MACHINE "DIED".

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2061532 DREAM MACHINE 2 CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC.

Patients

Seq Age Sex Outcome Treatment
1 81 YR Male Hospitalization