PHILIPS M1026B ANESTHETIC GAS MODULE
Received Oct 20, 2019 · Event occurred Sep 16, 2019
Report 3007409280-2019-00046 · MDR key 9212555
Device
Generic name
Anesthetic Gas Module
Manufacturer
Philips Medizin Systeme Boeblingen GmbhModel number
FGPH1026BProduct problems
- Improper Flow or Infusion
- Improper Flow or Infusion
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. INCOMING VISUAL INSPECTION DID NOT IDENTIFY ANY ANOMALIES. TECHNICAL VISUAL INSPECTION DID NOT IDENTIFY ANY ANOMALIES. TECHNICAL VISUAL INSPECTION CORNER DAMAGE ON THE TOP CASE. DEVICE EVALUATION FOUND THAT THE O2 MODULE HAD A COMMUNICATION ERROR AND THE O2 READING WAS TOO HIGH. ADDITIONALLY, THE PUMP WAS FAILING THE CALIBRATION FLOW CHECK. THE PUMP WAS REPLACED. THE O2 MODULE WAS REPLACED, AND THE O2 COMMUNICATING AND READING WAS SET AT THE CORRECT LEVEL. THE DEVICE WAS CALIBRATED AND THE TESTED TO OEM SPECIFICATION. THE FAN, FAN FILTER, FLOW RATE, GAS CALIBRATION AND SPAN TEST, LEAK CHECK, POWER ON TEST, AND PRESSURE SENSOR WERE ALL CHECKED ALL PASSED. THE ROOT CAUSE WAS DETERMINED TO BE THAT THE PUMP WAS AGED MOST LIKELY FROM LONG RUN HOURS. THIS WAS RELATED TO THE PREVIOUS REPAIR. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.
Description of Event or Problem
REPORTEDLY, POST REPAIR, THE O2 ANALYZING CHANNEL FAILED. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS REQUIRED.