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

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 11/23/2017

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.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.Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

The hospital reported the unit had a ventilator failure.There was no report of patient involvement.

Manufacturer Narrative

A gehc service representative performed a checkout of the equipment.The anesthesia control board was replaced.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7142637
• MDR Text Key: 95635845
• Report Number: 2112667-2017-02383
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042154
• 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: 01/10/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/10/2018
• 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: N
• Patient Sequence Number: 1