PHILIPS M1026B ANESTHETIC GAS MODULE
Received Feb 7, 2020
Report 3007409280-2020-00040 · MDR key 9684663
Device
Generic name
Anesthetic Gas Module
Manufacturer
Philips Medizin Systeme Boeblingen GmbhModel number
FGPH1026BProduct problems
- Complete Loss of Power
- Complete Loss of Power
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. DEVICE SENT IN DUE TO THE DEVICE SHUTTING DOWN IN THE MIDDLE OF A PROCEDURE. INCOMING VISUAL INSPECTION FOUND NO ANOMALIES. DEVICE EVALUATION FOUND NO PROBLEM. THE DEVICE WAS CALIBRATED, THE CASE AND FRONT/REAR CONNECTORS WERE INSPECTED. THE CIRCUIT BOARDS WERE INSPECTED. THE REPORTED EVENT WAS UNABLE TO BE DUPLICATED AND THERE WAS NO PROBLEM FOUND; THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED. IT SHOULD BE NOTED THAT THIS IS BEING FILED BASED ON RETROSPECTIVE REVIEW.
Description of Event or Problem
REPORTEDLY, POST REPAIR, THE DEVICE FAILED DURING A PROCEDURE AS IT SHUT OFF. THERE WAS NO REPORT OF PATIENT HARM OR INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.