FDA Adverse Event
Other
Summary report: N
STELLAR 100 - UK
MDR report key: 2718733
·
Received August 24, 2012
Report
- Report Number
- 3004604967-2012-00034
- Event Type
- Other
- Date Received
- August 24, 2012
- Date of Event
- July 20, 2012
- Report Date
- August 23, 2012
- Manufacturer
- RESMED GERMANY INC.
- Product Code
- MNT
- PMA / PMN Number
- K103167
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THE RETURNED DEVICE FOUND THE SYSTEM FAILURE WAS TRIGGERED BY AN OVER-PRESSURE SAFETY CONDITION. THIS LIKELY OCCURRED WHEN THE PT DISCONNECTED AND RECONNECTED THE HIGH IMPEDANCE PT CIRCUIT DURING THERAPY. THE DEVICE ALARM OPERATED AS INTENDED TO NOTIFY THE PT/USER OF THE FAILURE. NO PERMANENT INJURY WAS REPORTED AS RESULT OF THIS INCIDENT.
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED UK THAT A DEVICE HAD A SYSTEM FAILURE 6 AND FAILED TO VENTILATE, AT WHICH POINT THE PT REQUIRED BAGGING (MANUAL VENTILATION).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STELLAR 100 - UK | MNT | RESMED GERMANY INC. | 24155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |