MAUDE Adverse Event Report: DATEX-OHMEDA, INC AESTIVA 7900; ANESTHESIA MACHINE

Lot Number AMRS00259

Device Problems Failure to Sense (1559); Sticking (1597); Tidal Volume Fluctuations (1634)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2015

Event Type  malfunction  

Manufacturer Narrative

This malfunction was determined to be reportable as this same malfunction has previously contributed to a serious injury.Reference mdr 2112667-2013-00005.Manual mode of ventilation is available to maintain ventilation of the patient.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: (1) a hard impact, such as dropping the flow sensor, or by (2) 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.

Event Description

The hospital reportedly noted that tidal volume was not as expected.Upon inspection of the flow sensor, it was reportedly noted that the diaphragm was stuck to the top of the flow sensor housing.There was no report of patient involvement.

• Brand Name: AESTIVA 7900
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 4919356
• MDR Text Key: 22443573
• Report Number: 2112667-2015-00062
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K023366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: AMRS00259
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2013
• 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