FDA Adverse Event
Injury
Summary report: N
PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP
MDR report key: 13534337
·
Received February 15, 2022
Report
- Report Number
- MW5107415
- Event Type
- Injury
- Date Received
- February 15, 2022
- Date of Event
- January 24, 2022
- Report Date
- February 9, 2022
- Manufacturer
- PHILIPS / RESPIRONICS, INC.
- Product Code
- BZD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PHILIPS RESPIRONICS, INC., HAS ADVISED ME OF CPAP RECALL. MY CPAP IS ON THE LIST OF MACHINES BEING RECALLED. I HAVE EXPERIENCED LIGHT HEADEDNESS OR DIZZYNESS FOR OVER A YEAR. HAVE HAD CARDIOLOGIST CHECK ME OUT AND EVERYTHING IS OK. DON'T KNOW IF PRESCRIPTIONS COULD CAUSE CONDITION. FDA SAFETY REPORT ID # (B)(4).
Description of Event or Problem · 0
PHILIPS RESPIRONICS, INC., HAS ADVISED ME OF CPAP RECALL. MY CPAP IS ON THE LIST OF MACHINES BEING RECALLED. I HAVE EXPERIENCED LIGHT HEADEDNESS OR DIZZYNESS FOR OVER A YEAR. HAVE HAD CARDIOLOGIST CHECK ME OUT AND EVERYTHING IS OK. DON'T KNOW IF PRESCRIPTIONS COULD CAUSE CONDITION. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 585864 | PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | PHILIPS / RESPIRONICS, INC. | DREAM STATION AUTO CPAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male | AMLODIPINE BESYLATE 2.5 MG| ATORVASTATIN 10 MG| BENAZEPRIL 20 MG| CALCIUM CITRATE+D3| CULTURELLE| FINASTERIDE 5 MG| PANTOPRAZOLE 40 MG| PROSTATE PQ| SUCRALFATE 1 GM |