MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS CS2; ANESTHESIA GAS MACHINE

Model Number 1011-9050-000

Device Problems Mechanical Problem (1384); Suction Failure (4039)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No report of patient involvement.Unique identifier: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that the suction knob would not turn resulting in the inability to select desired level of suction.There was no report of patient involvement.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The suction regulator was replaced to resolve the reported issue.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 9601168
• MDR Text Key: 214804841
• Report Number: 2112667-2020-00173
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011-9050-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1