FDA Adverse Event Malfunction Summary report: N

AVANCE

MDR report key: 3874342 · Received April 18, 2014

Report

Report Number: 2112667-2014-00064
Event Type: Malfunction
Date Received: April 18, 2014
Date of Event: March 19, 2017
Report Date: March 27, 2014
Manufacturer: DATEX-OHMEDA
Product Code: BSZ
PMA / PMN Number: K032803
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST TWO YEARS. REFERENCE MDR 2112667-2013-00005. THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND NOTED THAT THE FLOW SENSOR DIAPHRAGM WAS STUCK OPEN. MANUAL MODE OF VENTILATION IS AVAILABLE TO MAINTAIN VENTILATION OF THE PT. FLOW SENSORS OF THIS TYPE ARE CUSTOMER REPLACEABLE, ARE RECOMMENDED FOR REPLACEMENT AFTER 3 MONTHS, AND ARE WARRANTED FOR 6 MONTHS. THE MAINTENANCE SCHEDULE IN THE USER REFERENCE MANUAL STATES: "REPLACE THE DISPOSABLE FLOW SENSOR (PLASTIC). UNDER TYPICAL USE, THE SENSOR MEETS SPECS FOR A MINIMUM OF 3 MONTHS." IN ENGINEERING EVAL, THE STUCK DIAPHRAGM HAS BEEN ABLE TO BE REPRODUCED BY: A HARD IMPACT, SUCH AS DROPPING THE FLOW SENSOR, OR BY STICKING AN OBJECT INTO THE FLOW SENSOR, CAUSING THE DIAPHRAGM TO STICK OPEN. IF A SENSOR IS SUBJECTED TO A HARD IMPACT, IT IS STILL UNLIKELY THAT THE DIAPHRAGM WILL GET STUCK IN THE OPEN POSITION. THIS FAILURE MODE REQUIRES AN IMPACT IN A VERY LIMITED ORIENTATION TO RESULT IN THE INERTIA NEEDED TO FORCE THE DIAPHRAGM INTO THE STUCK OPEN POSITION.

Description of Event or Problem · 1

THE HOSPITAL REPORTED THAT, DURING A PREOPERATIVE CHECKOUT OF THE EQUIPMENT, THE UNIT ALARMED REGARDING THE FLOW SENSORS. THERE WAS NO PT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
238493	AVANCE	ANESTHESIA GAS MACHINE	BSZ	DATEX-OHMEDA

Patients

Seq	Age	Sex	Outcome	Treatment
1