FLOW SENSOR
Received Oct 13, 2004 · Event occurred Oct 12, 2004
Report 550244 · MDR key 550244
Device
Generic name
Autoclavable Type
Manufacturer
Datex OhmedaModel number
1503-3244-000Catalog number
*
Lot number
AE0730
Product problems
- Failure to Cycle
- Repair
- Improper or Incorrect Procedure or Method
- Device Displays Incorrect Message
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE HOSPITAL INCIDENT REPORT STATES: THAT WHEN THE VENTILATOR WAS TURNED ON, A MESSAGE APPEARED STATING "VENT FAIL- INSPIRATORY FLOW SENSOR AND REPLACE INSPIRATORY FLOW SENSOR...TO GET VENTILATION TO WORK, FLIP SWITCH TO BAG MODE AND SWITCH BACK." AS REPORTED TO BIOMED, THE VENTILATOR WAS NOT TESTED BEFORE THE CASE AND THE FLOW SENSORS HAD BEEN REPLACED THE NIGHT BEFORE WITH THE NEWER, METALLIC TUBE STYLE, SENSORS.THE FLOW SENSOR UNIT WAS REPLACED AND VENTILATION BEGAN NORMALLY AFTER THAT.THE FLOW SENSOR ASSEMBLY WAS BROUGHT TO THE BIOMED DEPT FOR MORE TESTING AND INSTALLED IN THE BACKUP MACHINE. IMMEDIATELY UPON TURNING ON THE MACHINE, A "INSP FLOW SENSOR FAIL" MESSAGE APPEARED. THE SENSOR ASSEMBLY WAS REMOVED AND RE-CALIBRATED WITH SAME RESULT. ERROR MESSAGES DUPLICATE THE ONES REPORTED IN THE IR, INCIDENT REPORT. THERE WAS NO VISIBLE DAMAGE OR MOISTURE. STAFF RESPONDED CORRECTLY BY REPLACING THE FLOW SENSOR ASSEMBLY AND FILING AN INCIDENT REPORT.