FDA Adverse Event Injury Summary report: N

DREAMSTATION1 CPAP

MDR report key: 11965938 · Received June 8, 2021

Report

Report Number
MW5101772
Event Type
Injury
Date Received
June 8, 2021
Date of Event
October 30, 2020
Report Date
June 6, 2021
Manufacturer
PHILIPS RESPIRONICS INC.
Product Code
BZD
UDI-DI
00606959025639
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WAS EXPERIENCING SWOLLEN LYMPH GLANDS IN MY NECK (NECK FELT THICK), PRESSURE IN EARS, RINGING IN EARS, REDUCTION IN NECK MOTION, HEADACHE, AND EVENTUALLY HIGH BLOOD PRESSURE. I FIRST MADE AN APPT. WITH MY PA/PHYSICIAN GROUP. SHE RAN BLOOD WORK AND TOOK AN X-RAY, BUT NOTHING OUTSTANDING WAS FOUND. NEXT CAME AN ULTRASOUND OF MY NECK. NO SIGNIFICANT FINDINGS, EXCEPT SMALL THYROID NODULES. NEXT WAS A CAT SCAN WITH CONTRAST. AGAIN NOTHING OUTSTANDING WAS FOUND. NOW WE WERE AT (B)(6) AND I AM WORSENING, FEELING MISERABLE, AND CANNOT SLEEP. I DROVE MYSELF TO THE ER QUICKCARE IN (B)(6), AND NEXT STOP WOULD BE THE ER IF NO ASSISTANCE. I WAS EXAMINED AND IT WAS NOTED I HAD "SYMPTOMS WITH AN UNCERTAIN CAUSE", AND WAS PUT ON A STEROID (MEDROL) AND Z-PACK (AZITHROMYCIN). MY BP WAS VERY HIGH THAT DAY. HIGHEST WAS 170/99. I WAS VERY AGITATED AS THIS HAD BEEN GOING ON FOR 2 MONTHS. THE MEDICINE STARTED TO WORK WITHIN 24-48 HOURS AND MY NECK STARTED FEELING BETTER. MY NEXT APPOINTMENT WAS WITH AN ENT ON (B)(6) DR. (B)(6) LOOKED ME OVER THOROUGHLY AND NOTED MY SYMPTOMS WERE GETTING BETTER WITH TREATMENT. MY EAR PRESSURES WERE MEASURED AND WERE BOTH HIGHER THAN NORMAL. HE CONCLUDED, "I WAS ALLERGIC TO SOMETHING". I ASKED HIM WHAT IT COULD BE, SINCE I HAVE HAD VERY FEW ALLERGIC REACTIONS OR ALLERGIES THROUGHOUT MY LIFE (DOB (B)(6) HE WASN'T SURE, BUT PUT ME ON A REGIMEN OF FLONASE AND ZYRTEC DAILY. MY SYMPTOMS IMPROVED, BUT THE RINGING IN MY EARS REMAINS AND MY GLANDS SEEMED TO STAY SWOLLEN AND SENSITIVE TO THE TOUCH. A FOLLOW UP VISIT TO ENT SHOWED HIGH PRESSURES IN MY EARS REMAINED. I USE A PHILIPS RESPIRONICS DREAMSTATION CPAP EVERY NIGHT (SINCE (B)(6) 2018). I TOLD THIS TO MY ENT DOCTOR, BUT NO CORRELATION WAS MENTIONED. NOT UNTIL LATE (B)(6) 2021, WHEN I HEARD OF A PRODUCT HOLD ON THIS CPAP PRODUCT, DID I PUT TWO AND TWO TOGETHER TO HIGHLY SPECULATE THAT MY "ALLERGY" COULD BE THE DEGRADED FOAM BEING INVESTIGATED BY PHILIPS AND THE FDA. I HAVE BEEN WAITING FOR FURTHER INFORMATION AND CLARIFICATION ON RESEARCH, BUT TO DATE I HAVE NO MORE INFORMATION. I TOOK MYSELF OFF THE CPAP IMMEDIATELY AND REQUESTED A DIFFERENT UNIT FROM APRIA. NO ONE HAS BEEN ABLE TO GET ME A NEW DEVICE, SO I HAVE BEEN USING A NEW CPAP GO (PHILIPS RESPIRONICS ALSO) THAT I HAD BOUGHT, BUT HADN'T USED YET. FROM THE INFORMATION I HAVE FROM THE PHILIPS WEBSITE, THE CAUSE FOR THE DEGRADING FOAM COULD BE OZONE CLEANING, HIGH HUMIDITY AND/OR AGE. MY UNIT IS 3.5 YEARS OLD, I LIVE IN FL AND I USED OZONE CLEANING. I WOULD LIKE TO GET MY UNIT TESTED, BUT HAVEN'T FOUND A RELIABLE COMPANY YET. I WOULD LIKE TO FIND OUT IF THIS DEVICE HAS CAUSED MY REACTION AND WHAT LONG TERM AFFECTS IT COULD CAUSE. YOUR INPUT WOULD BE GREATLY APPRECIATED. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
859499 DREAMSTATION1 CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS RESPIRONICS INC. DSX500H11C 2018-11-19 00606959025639
859500 OZONE CLEANER DISINFECTOR, MEDICAL DEVICES MEC UNK

Patients

Seq Age Sex Outcome Treatment
1 60 YR Required Intervention| S