FDA Adverse Event
Injury
Summary report: N
DREAMSTATION AUTO CPAP
MDR report key: 17854089
·
Received October 2, 2023
Report
- Report Number
- 2518422-2023-25184
- Event Type
- Injury
- Date Received
- October 2, 2023
- Date of Event
- August 30, 2023
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- PMA / PMN Number
- K131982
- Removal / Correction Number
- Z-1974-2021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT: DEVICE NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 0
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHES, INFLAMMATORY RESPONSE, STROKE, BRONCHIAL INFLAMMATION, AND RESPIRATORY DISTRESS RESPONSE. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO OTHER INFORMATION HAS BEEN RECEIVED HOWEVER IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL/FOLLOW UP WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1977173 | DREAMSTATION AUTO CPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | DSX500H11C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |