FDA Adverse Event
Injury
Summary report: N
STELLAR 150
MDR report key: 4195320
·
Received September 25, 2014
Report
- Report Number
- 3004604967-2014-00022
- Event Type
- Injury
- Date Received
- September 25, 2014
- Manufacturer
- RESMED GERMANY INC.
- Product Code
- MNT
- PMA / PMN Number
- K122715
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN INVESTIGATED BY THE DESIGN FACILITY. THE RESULT OF THE ENGINEERING INVESTIGATION DETERMINED THE DEVICE OPERATED AS DESIGNED. THE STELLAR (B)(4) DEVICE IS EQUIPPED WITH MULTIPLE INTERNAL BATTERY ALARMS TO PROVIDE THE BATTERY LEVEL STATUS TO THE USER. THE INTERNAL BATTERY AND BATTERY ALARMS WERE FULLY TESTED AND FOUND TO BE WORKING PROPERLY. BASED ON THE INFORMATION PROVIDED FROM THE REPORTER, THE DEVICE WAS USED FOR A VENTILATOR-DEPENDENT PATIENT WHILE THE INDICATIONS FOR USE IS FOR NON-DEPENDENT PATIENTS.
Description of Event or Problem · 1
IMP REF # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 599387 | STELLAR 150 | CONTINUOUS VENTILATOR | MNT | RESMED GERMANY INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |