PHILIPS M1026B ANESTHETIC GAS ANALYZER
Received Dec 3, 2019 · Event occurred Nov 8, 2019
Report 3007409280-2019-00121 · MDR key 9406819
Device
Generic name
Anesthetic Gas Module
Manufacturer
Philips Medizin Systeme Boeblingen GmbhModel number
FGPH1026BProduct problems
- Electrical /Electronic Property Problem
- Mechanical Jam
- Electrical /Electronic Property Problem
- Mechanical Jam
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE COMPLAINT DEVICE WAS RETURNED. DEVICE EVALUATION IDENTIFIED THAT THE DEVICE CAME IN WITH THE MICRON FILTER DISCONNECTED AND THE PUMP WAS BAD. THE PUMP WAS REPLACED. THE FAN, FAN FILTER, FLOW RATE, GAS CALIBRATION, LEAK, POWER ON, PRESSURE SENSOR, AND FINAL VISUAL INSPECTION WERE CHECKED/TESTED AND ALL PASSED. THE ROOT CAUSE WAS DETERMINED TO BE THE DEFECTIVE PUMP. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.
Description of Event or Problem
REPORTEDLY, POST REPAIR, THE DEVICE'S O2 ZERO FAILED AND AGM ZERO FAILED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.