PHILIPS M1026B ANESTHETIC GAS ANALYZER
Received Nov 11, 2019 · Event occurred Oct 17, 2019
Report 3007409280-2019-00089 · MDR key 9307433
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 Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. INCOMING VISUAL INSPECTION FOUND NO ANOMALIES. TECHNICAL VISUAL INSPECTION FOUND NO ANOMALIES. DEVICE EVALUATION FOUND THAT THE MIRRORS HAD BROKEN OFF INSIDE OF THE DIR, THE PUMP WAS GRINDING METAL ON METAL AND SOLENOIDS #1 AND #2 OF THE PUMP HAD FAILED. DUE TO THE DAMAGE OF THE DEVICE IT WAS NOT REPAIRED; HOWEVER, IT WAS EXCHANGED. THE ROOT CAUSE FOR THE CONFIRMED REPORTED MALFUNCTION WAS DETERMINED TO BE THE DIR PUMP AND PNEUMATIC ASSEMBLY DUE TO LONG RUN HOURS AND NORMAL WEAR AND TEAR. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.
Description of Event or Problem
REPORTEDLY, POST REPAIR, THE DEVICE WAS GETTING A 02 ASSEMBLY FAILURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.