FDA Adverse Event Injury Summary report: N

PHILLIPS DREAM STATION

MDR report key: 12134770 · Received July 6, 2021

Report

Report Number
MW5102333
Event Type
Injury
Date Received
July 6, 2021
Date of Event
June 26, 2021
Report Date
July 2, 2021
Manufacturer
PHILLIPS / RESPIRONICS INC.
Product Code
BZD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I PASSED OUT AT HOME DUE TO ISSUES FROM NOT USING MY CPAP MACHINE FOR 2 WEEKS DUE TO THE RECALL OF THE PHILIPS DREAMMACHINE. I HAVE NOT BEEN SLEEPING WELL AND WAKE OFTEN TO FIND MYSELF NOT BREATHING. I THEN TAKE DEEP BREATHS UNTIL I CAN FALL ASLEEP AGAIN. THIS HAS BEEN TAKING PLACE FOR THE LAST 2 WEEKS SINCE THE RECALL. I HAVE TOLD MY CPAP DR THAT I NEED ANOTHER MACHINE SUCH AS THE RES-MED BUT HE DOES NOT RETURN MY CALLS. I ALSO TOLD MY PRIMARY CARE DR BUT SHE TOLD ME I HAVE TO HANDLE THE SITUATION WITH THE DR WHO GAVE ME THE PRESCRIPTION FOR MY ORIGINAL CPAP MACHINE. THE EMERGENCY ROOM DR DID SEND A MESSAGE TO MY DR BUT THE DR DID NOT RESPOND. I CAN PURCHASE A RES-MED CPAP FROM A MEDICAL SUPPLIES COMPANY BUT THEY COST AROUND (B)(6) AND I AM ON A FIXED INCOME AND CAN'T AFFORD IT. EMERGENCY ROOM DR REFERED A CARDIOLOGIST FOR ME TO SEE WHY I PASSED OUT AT HOME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1021027 PHILLIPS DREAM STATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS INC.

Patients

Seq Age Sex Outcome Treatment
1 67 YR Hospitalization