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

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The absorber panel switch was replaced, and the unit was returned to service.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.Date of device manufacture was unavailable at time of mdr filing.

Event Description

The hospital reported the unit had an alarm that could result in a loss of mechanical ventilation.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that there was no loss of mechanical ventilation.The unit alarmed, notifying the user of the reported condition.Unit continues to ventilate and alarms remain functional.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 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI 53188 ; 8479711808
• MDR Report Key: 7268696
• MDR Text Key: 100006635
• Report Number: 2112667-2018-00283
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K023366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly