FDA Adverse Event Malfunction Summary report: N

AESPIRE 7900

MDR report key: 3800544 · Received February 11, 2014

Report

Report Number: 2112667-2014-00021
Event Type: Malfunction
Date Received: February 11, 2014
Date of Event: January 23, 2014
Report Date: January 23, 2014
Manufacturer: DATEX-OHMEDA
Product Code: BSZ
PMA / PMN Number: K050626
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NE, US
Reporter Occupation: BIOMEDICAL ENGINEER

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 YRS. REFERENCE MDR 2112667-2013-00005. THE HOSPITAL BIOMED PERFORMED A CHECKOUT OF THE EQUIPMENT AND NOTED THAT THE FLOW SENSOR DIAPHRAGM WAS STUCK OPEN. THE UNIT WILL CONTINUE TO ALARM UNTIL THE FLOW SENSOR TO REPLACED. 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. 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 THE UNIT ALARMED 'VOLUME MISMATCH' DURING A CASE. THERE WAS NO REPORTED PT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
90351	AESPIRE 7900	ANESTHESIA GAS MACHINE	BSZ	DATEX-OHMEDA

Patients

Seq	Age	Sex	Outcome	Treatment
1	36 YR