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

Model Number 1006-9117-000

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.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported the unit was not able to perform fluid suctioning.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that the suction failure was not confirmed.The equipment was checked and found to function within manufacturing specifications.The reported complaint could not be duplicated and would be noted during preuse testing, as contained in the user manual.Standard of care includes ensuring adequate backup equipment.The reported complaint will not affect delivery of o2, agent or ventilation from the anesthesia machine.The initial event was not reportable.

• 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: 7454360
• MDR Text Key: 106386927
• Report Number: 2112667-2018-00832
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1006-9117-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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