MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C20; GAS-MACHINE, ANESTHESIA

Model Number C20

Device Problems Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2016

Event Type  malfunction  

Event Description

It was reported that during patient treatment, the anesthesia workstation switched from automatic ventilation to manual ventilation without user interaction.There was no patient harm reported.(b)(4).

Manufacturer Narrative

Our company field service engineer (fse) investigated the anesthesia workstation at the hospital.The reported issue could not be reproduced.The switch for changing ventilation mode between manual and automatic ventilation(man/auto switch)was replaced preventively and the anesthesia workstation was returned to service after successful safety and functional tests were performed.The device logs were saved and were sent for investigation together with the replaced part.The returned man/auto switch was visually inspected and tested in a reference anesthesia workstation.No deviations were noticed.Electrical measurements were performed and the switch was disassembled for inspection of the interior components of the switch.No deviations could be seen.There were no obvious reasons for the switch to change states from automatic ventilation to manual ventilation without user interaction noticed.The device logs confirmed that the ventilation mode changed from automatic ventilation mode to manual ventilation mode at the time reported by the user.The log does not reveal why the change of ventilation mode occurred.There were no recordings in the technical logs to support any root cause.Based on our findings, we have not been able to determine the root cause for the reported issue.

Event Description

(b)(4).

• Brand Name: FLOW-I C20
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 6176958
• MDR Text Key: 62842653
• Report Number: 8010042-2016-00569
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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