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

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The flow valve was replaced, and the unit was returned to service.No report of patient involvement.Date of manufacture year is 2003.Day and month are unavailable at time of mdr filing.

Event Description

The hospital reported the flow valve would stick intermittently causing a loss of mechanical ventilation.There was no report of patient involvement.

• Brand Name: AESTIVA 7900
• Type of Device: ANETHESIA 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: john szalinski ; 540 w. northwest highway; barrington, IL 60010
• MDR Report Key: 5541942
• MDR Text Key: 41679721
• Report Number: 2112667-2016-00624
• 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
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 04/01/2016
• 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