FDA Adverse Event
Malfunction
Summary report: N
KION
MDR report key: 313688
·
Received January 23, 2001
Report
- Report Number
- 8010042-2001-00001
- Event Type
- Malfunction
- Date Received
- January 23, 2001
- Date of Event
- November 29, 2000
- Report Date
- November 29, 2000
- Manufacturer
- SIEMENS-ELEMA AB LIFE SUPPORT SYSTEMS DIVISION
- Product Code
- BSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE UNIT IS SHOWING REPETITIVE "MVE<0.4 L/MIN" FOLLOWED BY "DISCONNECT-CHECK TUBING" IN THE ALARM HISTORY. THESE ALARMS OCCURRED AROUND THE TIME OF THE INCIDENT AND ARE THE ONLY ALARMS INDICATED HISTORY UNTIL THE UNIT WAS DISCONNECTED FROM GAS SUPPLIES, TO BE REMOVED FROM THE OPERATING ROOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2882 | KION | ANESTHESIA SYSTEM | BSZ | SIEMENS-ELEMA AB LIFE SUPPORT SYSTEMS DIVISION | KION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |