FDA Adverse Event
Malfunction
Summary report: N
SERVO I
MDR report key: 500609
·
Received November 18, 2003
Report
- Report Number
- 8010042-2003-00304
- Event Type
- Malfunction
- Date Received
- November 18, 2003
- Date of Event
- November 4, 2003
- Report Date
- November 17, 2003
- Manufacturer
- SERVOCARE SYSTEMS AB
- Product Code
- CBK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
DURING TRANSPORT IN THE EMERGENCY ELEVATOR TO RADIOTHERAPY DEPARTMENT, VENTILATOR ALARMS "TECHNICAL ERROR 20002" 30-60 SECONDS, THEN VENTILATOR STOPS WORKING. BACK-UP BATTERY WAS CHECKED BEFORE AND SHOWS 52 MINUTE BATTERY. REPLACED, THEREAFTER OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO I | RESPIRATORY VENTILATOR | CBK | SERVOCARE SYSTEMS AB | 6487800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |