PHILIPS ANESTHESIA GAS MONITOR
Received Sep 23, 2019 · Event occurred Aug 27, 2019
Report 3007409280-2019-00020 · MDR key 9106792
Device
Generic name
Anesthetic Gas Module
Manufacturer
Philips Medizin Systeme Boeblingen GmbhModel number
M1026BProduct problems
- Pumping Problem
- Unexpected Shutdown
- Pumping Problem
- Unexpected Shutdown
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 IDENTIFIED CASE DAMAGE AND THAT THERE WAS NO WATER TRAP. TECHNICAL VISUAL INSPECTION IDENTIFIED NO ANOMALIES. DEVICE EVALUATION FOUND THAT THE PUMP WAS VERY WEAK. THIS WAS NOT RELATED TO THE PREVIOUS REPAIR AS THIS IS PART WAS NOT REPAIRED AT THAT TIME. THE PUMP WAS REPLACED AND THE DEVICE TESTED TO OEM SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THE DEVICE TURNING OFF COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT IT WAS RELATED TO THE BAD PUMP. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.
Description of Event or Problem
REPORTEDLY, POST REPAIR, THE DEVICE TURNS OFF DURING USE. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.