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

Model Number 1009-9050-000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For 5 of the 5 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.To resolve the reported events, the flow sensor was replaced.

Event Description

This report summarizes 5 malfunction events.A review of the events indicated that model 1009-9050-000 anesthesia gas machine experienced flow sensor malfunction that cause a loss of mechanical ventilation.These reports were received from various sources.Of the 5 events, 4 did not involve patients, and 1 did involve a patient.There was no patient information available.

• Brand Name: AVANCE CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 8786450
• MDR Text Key: 151024928
• Report Number: 2112667-2019-00271
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00840682102322
• UDI-Public: 010084068210232221
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1009-9050-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2019
• 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