FDA Adverse Event Malfunction Summary report: N

THE DREAMSTATION AUTOBIPAP MACHINE

MDR report key: 12569557 · Received October 1, 2021

Report

Report Number
MW5104359
Event Type
Malfunction
Date Received
October 1, 2021
Date of Event
July 26, 2021
Report Date
September 29, 2021
Manufacturer
PHILIPS / RESPIRONICS, INC.
Product Code
BZD
UDI-DI
00606959025707
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

RECEIVED A NOTICE FROM PHILIPS RESPIRONICS ABOUT THE SLEEP APNEA MACHINE I USE, THE DREAMSTATION #SN(B)(4) TELLING ME THAT PARTICULAR MODEL IS BEING RECALLED DUE TO DANGEROUS PARTICULATES THAT ARE FROM THE DISINTEGRATION FROM A FOAM SEAL AND THAT THOSE PARTICULATES THEN TRAVEL THROUGH THE HOSE AND GO DIRECTLY TO THE LUNGS CAUSING IRRITATION AND OTHER MORE SERIOUS PROBLEMS. NOT USING IT AND I STOP BREATHING MANY TIMES A MINUTE ALL THROUGH THE NIGHT. AS A PATIENT WITH APNEA, COPD, AND CONGESTIVE HEART FAILURE THIS MACHINE HELPS PROLONG THE QUALITY AND LENGTH OF MY LIFE. THE SECONDARY PROBLEM OF NOT HAVING THAT BEDSIDE AIDE IS THAT PHILIPS HAS NO SATISFACTORY ANSWER OF HOW LONG BEYOND A YEAR WILL I AND MILLIONS OF OTHERS BE WITHOUT THIS DEVICE. I DON'T SEE WHY THEY CAN'T MANUFACTURE A NEW FOAM SEAL AND TRAIN MANY PEOPLE IN EVERY STATE TO CHANGE THEM OUT FOR USERS OR PROVIDE OLDER MACHINES, (BTW, THE MACHINE IS IN PERFECT WORKING ORDER OTHER THAN THOSE PESKY PARTICULATES), AT NO COST TO USERS THAT WORKED FINE BEFORE THE DREAMSTATION WAS CREATED. I SPENT THE BETTER PART OF A DAY BEFORE I REACHED YOUR OFFICES TRYING TO GET INFORMATION, AND ALL I GOT WAS SHUFFLED TO THE NEXT PHONE NUMBER AND OFFICE AND NO ONE HAD ANSWERS OR INFORMATION. THIS IS CPAP. PLEASE HAVE THE COURTESY TO ANSWER ME THROUGH AN EMAIL BEFORE THE END OF NEXT WEEK. A QUOTE FROM THE PHILIPS DREAMSTATION HANDBOOK: "RESPIRONICS, INC WARRANTS THAT THE SYSTEM SHALL BE FREE FROM DEFECTS OF WORKMANSHIP AND MATERIALS AND WILL PERFORM IN ACCORDANCE WITH THE PRODUCT SPECIFICATION FOR A PERIOD OF (2) YEARS FROM THE DATE OF SALE BY RESPIRONICS, INC. TO THE DEALER. IF THE PRODUCT FAILS TO PERFORM IN ACCORDANCE WITH THE PRODUCTS SPECIFICATIONS, RESPIRONICS, INC. WILL REPAIR OR REPLACE- AT ITS OPTION-THE DEFECTIVE MATERIAL OR PART. RESPIRONICS, INC. WILL PAY CUSTOMARY FREIGHT CHARGES FROM RESPIRONICS, INC. TO THE DEALER LOCATION ONLY". MY MACHINE WAS BOUGHT 1+1/2 YEARS AGO. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1463859 THE DREAMSTATION AUTOBIPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. DSX700 00606959025707

Patients

Seq Age Sex Outcome Treatment
1 74 YR Other