MAUDE Adverse Event Report: DATEX-OHMEDA, INC AESPIRE VIEW; ANESTHESIA GAS MACHINE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

The hospital reported that, during a case, the set tidal volume was 350 ml, delivered tidal volume was 250 ml, and the unit alarmed for a system leak.There was no reported patient injury.

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.A ge healthcare service representative performed a checkout of the equipment and noted that the flow sensor diaphragm was stuck to the top of the flow sensor housing.The unit will continue to alarm until the flow sensor is replaced.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: 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: AESPIRE VIEW
• Type of Device: ANESTHESIA GAS 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: 4343197
• MDR Text Key: 16083003
• Report Number: 2112667-2014-00124
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/03/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 79