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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.The distributor performed a checkout of the equipment and confirmed the reported complaint.The ventilator interface board was replaced.

Event Description

The hospital reported that, during the preoperative checkout, the unit had a failure affecting mechanical ventilation.There was no report of patient involvement.

• Brand Name: AVANCE CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7635161
• MDR Text Key: 112231000
• Report Number: 2112667-2018-01276
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K123125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 06/25/2018

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
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• 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