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

Device Problem Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.No report of patient involvement.Date of device manufacture year is 2006.The month of manufacture was unavailable at time of mdr filing.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported suction was not functioning.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that a ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The suction regulator was replaced, and the unit was returned to service.

• Brand Name: AESTIVA 7900
• Type of Device: ANETHESIA MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7463196
• MDR Text Key: 106609646
• Report Number: 2112667-2018-00853
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2006
• 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