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

Device Problem Tidal Volume Fluctuations (1634)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2016

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.A distributor performed a checkout of the equipment and confirmed the reported complaint.A parts quote has been issued to the user for the replacement of the confirmed faulty sensor interface board but has not been accepted at this time.

Event Description

The hospital reported the unit alarmed during pre-use checkout and lost the ability to mechanically ventilate.There was no report of patient involvement.

• Brand Name: AESTIVA MRI
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 6228494
• MDR Text Key: 64037179
• Report Number: 2112667-2017-00043
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K993410
• 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: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• 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: 12/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2004
• 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