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

Lot Number ANBQ00191

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare service issued a cost estimate for repair that was no approved by the customer.No further information is available regarding the resolution of the reported issue.Legal manufacturer: (b)(4).

Event Description

The hospital reported that when switching to switched common gas outlet (scgo), the "no fresh gas flow" alarm will occur.There was no report of patient involvement.

• Brand Name: AVANCE
• 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: 11610977
• MDR Text Key: 243835628
• Report Number: 2112667-2021-00923
• 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: foreign,health professional,u
• Type of Report: Initial
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: ANBQ00191
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2011
• 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