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

Device Problem Infusion or Flow Problem (2964)

Patient Problems Awareness during Anaesthesia (1707); No Consequences Or Impact To Patient (2199)

Event Date 12/21/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Serial not provided.Date of device manufacture not available as no serial number was provided.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a malfunction resulting in light anesthesia causing the patient to wake up during the procedure.There was no report of patient injury.

Manufacturer Narrative

The reported event was caused by a tpx sensor on the gas module.There is no reported failure of the aisys unit.Block d4 serial number updated.Block h4 date of device manufacture updated.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 9617667
• MDR Text Key: 200791279
• Report Number: 2112667-2020-00236
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K172045
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• 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: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1