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

Model Number AESTIVA 5

Device Problem Suction Problem (2170)

Patient Problem No Information (3190)

Event Date 06/16/2017

Event Type  malfunction  

Event Description

Bile was sucked into the anesthesia vacuum line filter.

• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr; madison WI 53718
• MDR Report Key: 7078572
• MDR Text Key: 93591257
• Report Number: 7078572
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/08/2017,11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AESTIVA 5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2017
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, PATIENT WAS BEING SUCTIONED.; YES THE SUCTION LINES.