MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7900; ANESTHESIA GAS MACHINE

Device Problem Tidal Volume Fluctuations (1634)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

A 3rd party service representative performed a checkout of the system and confirmed a defective flow sensor.The flow sensor was replaced to fix the reported issue.

Event Description

The 3rd party service technician found that the tidal volume is not achieving as per the set value.This would affect the tidal volume monitoring.There was no reported patient involvement.

• Brand Name: AESPIRE 7900
• 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: joseph seliga ; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 5998265
• MDR Text Key: 56416971
• Report Number: 2112667-2016-01944
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K050626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2016
• Date Device Manufactured: 07/18/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1