FDA Adverse Event
Death
Summary report: N
PHILIPS DREAMSTATION
MDR report key: 12568673
·
Received October 1, 2021
Report
- Report Number
- MW5104331
- Event Type
- Death
- Date Received
- October 1, 2021
- Date of Event
- July 1, 2018
- Report Date
- September 29, 2021
- Manufacturer
- PHILIPS / RESPIRONICS, INC.
- Product Code
- BZD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
MY HUSBAND USED A PHILIPS DREAMSTATION CPAP MACHINE EVERY NIGHT FOR ABOUT A YEAR BEFORE HE BEGAN EXPERIENCING SHOULDER PAIN. AFTER GOING TO SEVERAL DOCTORS, HE WAS DIAGNOSED WITH LUNG CANCER IN THE FALL OF 2018 AND DIED IN (B)(6) OF 2019. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1463875 | PHILIPS DREAMSTATION | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | PHILIPS / RESPIRONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death |