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

Lot Number APKY01140

Device Problem No Device Output (1435)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Legal manufacturer: hcs (b)(4).A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The gas mixer, ventilator board, solenoid, and flow control valve were replaced to resolve the reported issue.Date received by manufacturer: this mdr malfunction event was previously eligible for the voluntary malfunction summary reporting (vmsr) program.As of 9/16/2019 notification from fda, this product code is no longer eligible for vmsr.According to the notification, ge healthcare must submit individual reports within 30 calendar days of receiving the notification.Therefore, this event is being reported as an individual mdr report due 10/16/2019.

Event Description

The hospital reported an error message preventing 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 53718
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 9085090
• MDR Text Key: 196167097
• Report Number: 2112667-2019-00432
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: APKY01140
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2019
• 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