FDA Adverse Event
Injury
Summary report: N
PHILIPS RESPIRONICS CPAP BY PAP
MDR report key: 12066486
·
Received June 24, 2021
Report
- Report Number
- MW5102130
- Event Type
- Injury
- Date Received
- June 24, 2021
- Report Date
- June 22, 2021
- Manufacturer
- PHILIPS / RESPIRONICS, INC.
- Product Code
- BZD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
RECALL ON CPAP MACHINE DUE TO FOAM CONTAMINATION FROM MACHINE THAT CAUSED SINUS AND LUNG AND POSSIBLY KIDNEY AND BLADDER ISSUES .QUIT USING AND REVERTED TO OLD MACHINE AND FILED CLAIM WITH MANUFACTURER FOR REPLACEMENT IN THERE DETAILS I HAVE ALL SYMPTOMS OF POSSIBLE CAUSE OF FOAM PARTICLES BEING INGESTED FAMILY DOCTOR TREATMENT OF ANTIBIOTICS. SINUS HEADACHE SINUS INFECTION BRONCHITIS AND KIDNEY INFECTION. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 957524 | PHILIPS RESPIRONICS CPAP BY PAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | PHILIPS / RESPIRONICS, INC. | DREAM STATION AUTO CPAP DOM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |