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

Device Problem Gas Output Problem (1266)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/22/2016

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.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that, during a case, anesthetic agent output was noted to spike.The patient reportedly became hypotensive and was reportedly given a vasopressor to address.There was no reported patient injury.

Manufacturer Narrative

The hospital inspected the equipment and noted that the inflow/outflow/scavenging solenoid valve was free moving.Gehc recommended to the hospital to apply silicone to the mounting post to help prevent unwanted movement.The hospital inspected the equipment and noted that the inflow/outflow/scavenging solenoid valve was free moving.Gehc recommended to the hospital to apply silicone to the mounting post to help prevent unwanted movement.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL
• MDR Report Key: 6194500
• MDR Text Key: 62976898
• Report Number: 2112667-2016-02493
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042154
• 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: 01/19/2017

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 56