FDA Adverse Event
Injury
Summary report: N
REP DREAMSTATION AUTO
MDR report key: 18779619
·
Received February 26, 2024
Report
- Report Number
- 2518422-2024-09828
- Event Type
- Injury
- Date Received
- February 26, 2024
- Date of Event
- February 14, 2024
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- PMA / PMN Number
- K131982
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : THE DEVICE NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A REPAIRED DREAMSTATION AUTO BIPAP DEVICE. THE PATIENT ALLEGED EXPERIENCING BURNING NOSE AND THROAT. THE PATIENT WAS ALLEGED TO BE HOSPITALIZED TWICE DUE TO THE CONDITION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296595 | REP DREAMSTATION AUTO | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | UDSX700S11F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Hospitalization |