inforMED
MalfunctionCBQ

PHILIPS M1026B ANESTHETIC GAS ANALYZER

Received Dec 2, 2019 · Event occurred Nov 5, 2019

Report 3007409280-2019-00120 · MDR key 9399544

Device

Generic name

Anesthetic Gas Module

Model number

FGPH1026B

Product problems

  • Electrical /Electronic Property Problem
  • Improper Flow or Infusion
  • Material Integrity Problem
  • Electrical /Electronic Property Problem
  • Improper Flow or Infusion
  • Material Integrity Problem

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE COMPLAINT DEVICE WAS RETURNED. DEVICE EVALUATION IDENTIFIED THAT THE TOP CASE DAMAGED AND THE BOTTOM CASE LOCKING CAM WAS BROKEN. THE ERROR LOG SHOWED SOLENOID 1 AND 2 FAILURE, AND THE LAMP WAS ONLY READING CO2 UP TO 4.7. THE UNIT WAS RAN FOR 28 HOURS CONFIRMING THE INTERMITTENT CONNECTION AND FAILURE TO ZERO OUT. THE PUMP OUTLET FILTER, LAMP, LOCKING CAM, TOP CASE, AND RS232 CABLE WERE ALL REPLACED. THE UNIT WAS TESTED FOR 24 HOURS SHOWING THAT THE SOLENOID ISSUE 1 AND 2, CONNECTION, AND ZERO ISSUES RESOLVED. THE ROOT CAUSE WAS DETERMINED TO BE THE MICRON FILTER AND RS232 CABLE. AS THE PUMP IS RAN SHAVINGS FROM PUMP ARE CAUGHT PURPOSELY BY MICRON FILTER CAUSING IT TO FILL UP OVER TIME. THE RS232 CABLE SHOWED NORMAL WEAR AND TEAR DUE TO LONG RUN HOURS. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

Description of Event or Problem

REPORTEDLY, POST REPAIR, THE DEVICE WOULD NOT ZERO AND DISPLAYED 02 ASSEMBLY FAILURE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE.