MAUDE Adverse Event Report: AVANCE; ANESTHESIA GAS MACHINE

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 06/13/2021

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.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a malfunction causing the unit to not switch to battery power when ac power is lost resulting in the loss of mechanical ventilation.There was no report of patient involvement.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The breathing system was replaced to resolve the issue.

• Brand Name: AVANCE
• Type of Device: ANESTHESIA GAS MACHINE
• MDR Report Key: 12119170
• MDR Text Key: 262419505
• Report Number: 2112667-2021-01683
• 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,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2008
• 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