FDA Adverse Event Malfunction Summary report: N

AISYS

MDR report key: 4093810 · Received September 10, 2014

Report

Report Number: 4093810
Event Type: Malfunction
Date Received: September 10, 2014
Date of Event: June 16, 2014
Report Date: September 10, 2014
Manufacturer: GE - DATEX OHMEDA INC.
Product Code: UNK
Product Problem: Yes
Report Source: User Facility report
Reporter Location: WI, US

Narratives

Description of Event or Problem · 1

COMPLETE FAILURE OF ANESTHESIA MACHINE. THE FAILURE OCCURRED FOLLOWING INDUCTION AND APPROXIMATELY 10-MINUTES INTO THE ANESTHETIC DELIVERY OF THE SECOND CASE OF THE DAY. NO PROBLEMS WERE NOTED DURING THE 1ST CASE, WHERE THE SAME MACHINE WAS USED. THE PATIENT WAS ON MECHANICAL VENTILATION AND NORMAL MACHINE OPERATION WAS NOTED. THE CIRCUIT WAS THEN DISCONNECTED SO THAT THE PATIENT COULD BE TURNED TO BE PRONE. THE CIRCUIT WAS RECONNECTED AND THE VENTILATION SELECTOR SWITCH WAS TURNED TO MANUAL. THE SELECTOR SWITCH WAS THEN TURNED BACK TO VENTILATION MODE, WHICH IS WHEN THE PROBLEM OCCURRED. DURING THIS TRANSITION, THE FOLLOWING FAILURE CONDITIONS OCCURRED: 1. MACHINE VENTILATOR DISPLAY WENT BLANK. 2. HIGH PITCHED NOISE FROM THE ANESTHESIA MACHINE. 3. BELLOWS WERE UP, BUT NOT MOVING. 3. O2 FLUSH WAS PRESSED, BUT THERE WERE NO SIGNS OF IT WORKING (MANUAL BAG OR BELLOWS) WERE NOT FILLING AND THERE WAS NO "WHOOSHING" SOUND SIGNIFYING ANY GAS FLOW. OTHERS CAME IN AND CYCLED THE POWER ON THE MACHINE, BUT OPERATION WAS NOT RESTORED. THE AC POWER INDICATOR WAS NOTED TO BE LIT.DEVICE PASSED PRE-USE CHECK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
559775	AISYS	GAS-MACHINE, ANESTHESIA	UNK	GE - DATEX OHMEDA INC.	AISYS	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR			NO.