MAUDE Adverse Event Report: DATEX-OHMEDA INC. AESTIVA; ANESTHESIA MACHINE

Device Problems Fluid/Blood Leak (1250); Device Sensing Problem (2917)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2013

Event Type  malfunction  

Event Description

During a preoperative checkout, the hospital reportedly noted leakage in the flow sensor.There was no patient involvement.

Manufacturer Narrative

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.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 specifications for a minimum of 3 months." in engineering evaluation, 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.

• Brand Name: AESTIVA
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): DATEX-OHMEDA INC.; madison WI
• Manufacturer (Section G): DATEX-OHMEDA INC.; madison WI
• Manufacturer Contact: joy sonsalla ; 3000 n. grandview blvd.; waukesha, WI 53188 ; 2625482661
• MDR Report Key: 3767114
• MDR Text Key: 4486955
• Report Number: 2112667-2014-00002
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K973896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1