FDA Adverse Event
Malfunction
Summary report: N
REP DREAMSTATION ST30
MDR report key: 20490657
·
Received October 21, 2024
Report
- Report Number
- 2518422-2024-63855
- Event Type
- Malfunction
- Date Received
- October 21, 2024
- Date of Event
- October 9, 2023
- Report Date
- October 22, 2024
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- MNS
- UDI-DI
- 00606959063433
- PMA / PMN Number
- K102465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2024-62047. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT. PLEASE DISREGARD THIS MDR 2518422-2024-63855.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED DIZZINESS AND/OR HEADACHE. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 960441 | REP DREAMSTATION ST30 | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING | MNS | RESPIRONICS, INC. | DSX1030S11F | 00606959063433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |