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

Model Number 1009-9050-000

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

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

There was no ge employee visit to this site, and therefore the repair is unknown.No further information is available.No report of patient involvement.Udi # (b)(4).

Event Description

The hospital reported the suction control module cannot be adjusted which could result in inability to perform suction.There was no 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: john szalinski
• MDR Report Key: 9560320
• MDR Text Key: 219762943
• Report Number: 2112667-2020-00069
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1009-9050-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• 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