FDA Adverse Event
Death
Summary report: N
DREAMSTATION CPAP PRO DOM
MDR report key: 14084237
·
Received April 11, 2022
Report
- Report Number
- MW5108883
- Event Type
- Death
- Date Received
- April 11, 2022
- Report Date
- April 7, 2022
- Manufacturer
- PHILIPS / RESPIRONICS, INC.
- Product Code
- BZD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ONGOING RESPIRATORY ISSUES; DIZZINESS; MOOD CHANGES. CPAP PRO DOM. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 787372 | DREAMSTATION CPAP PRO DOM | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | PHILIPS / RESPIRONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization| D |