FDA Adverse Event
Death
Summary report: N
PHILIPS RESPIRONICS REMSTAR AUTO, DOM
MDR report key: 14675334
·
Received June 10, 2022
Report
- Report Number
- MW5110245
- Event Type
- Death
- Date Received
- June 10, 2022
- Report Date
- June 8, 2022
- Manufacturer
- PHILIPS / RESPIRONICS, INC.
- Product Code
- BZD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER CAREGIVERS
- Health Professional
- *
Narratives
Description of Event or Problem · 0
(B)(6) BEGAN USING THE PHILIPS CPAP IN 2015. IN THE YEAR 2021 HER DOCTOR CALLED AND RECOMMENDED SHE GET A NEW ONE. DURING THAT SAME YEAR SHE CAME DOWN WITH A CHRONIC COUGH. WHEN SHE VISITED A DOCTOR IN (B)(6) OF 2021 SHE WAS DIAGNOSED WITH LUNG CANCER. BECAUSE OF COVID IT WAS DIFFICULT TO GET ALL OF THE SCANS REQUIRED FOR PROPER CANCER TREATMENT. IN (B)(6) THE PET SCAN SHOWED (B)(6) HAD CANCER SPREAD THROUGH OUT HER ENTIRE BODY: INCLUDING ORANGE SIZE TUMORS IN HER LUNGS, LIVER, SPLEEN. CANCER WAS ALSO FOUND IN HER BONES AND SPINE AND EVENTUALLY HER BRAIN. (B)(6) PASSED AWAY ON (B)(6) 2022. A FEW WEEKS LATER WE RECEIVED THE PHILIPS RECALL LETTER. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1965959 | PHILIPS RESPIRONICS REMSTAR AUTO, DOM | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | PHILIPS / RESPIRONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Disability| L| O| H| D |