FDA Adverse Event
Injury
Summary report: N
PHILIPS RESPIRONICS DREAMSTATION CPAP HUMID DM
MDR report key: 13472704
·
Received February 4, 2022
Report
- Report Number
- MW5107243
- Event Type
- Injury
- Date Received
- February 4, 2022
- Date of Event
- December 15, 2021
- Report Date
- February 2, 2022
- Manufacturer
- PHILIPS / RESPIRONICS, INC.
- Product Code
- BZD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NV, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
SUDDEN ONSET RARE COMBINATION OF LEUKEMIA DIAGNOSIS: CLL, AML, AND MDS, FELL ILL IN (B)(6) 2021, DIAGNOSED IN (B)(6) 2021. "PLEASE BE CLEAR REGARDING WHAT KIND OF LAB RESULTS YOU ARE REQUESTING? FOR THE SLEEP APNEA DIAGNOSIS, OR FOR THE CANCER DIAGNOSIS." THANK YOU. FDA SAFETY REPORT ID# (B)(4).
Description of Event or Problem · 0
SUDDEN ONSET RARE COMBINATION OF LEUKEMIA DIAGNOSIS: CLL, AML, AND MDS, FELL ILL IN (B)(6) 2021, DIAGNOSED IN (B)(6) 2021. "PLEASE BE CLEAR REGARDING WHAT KIND OF LAB RESULTS YOU ARE REQUESTING? FOR THE SLEEP APNEA DIAGNOSIS, OR FOR THE CANCER DIAGNOSIS." THANK YOU. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1373556 | PHILIPS RESPIRONICS DREAMSTATION CPAP HUMID DM | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | PHILIPS / RESPIRONICS, INC. | DSX200H11 | 2017-04-06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Life Threatening| S| H | AZACITIDINE |