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

Model Number C20

Device Problems Inaccurate Delivery (2339); Improper Flow or Infusion (2954)

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

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

There has been no technical investigation performed on the concerned anesthesia workstation.The logs were collected and sent in for our evaluation but, the logs do not confirm the event.The reported issue can however, be verified in the received screen dumps that were saved during the event.Based on tests performed in prior reported issues of a similar kind, we have concluded that the startup configuration chosen by the user is intermittently not retrieved by the system.This leads to a lower fio2 concentration in the fresh gas flow delivered to the patient.Alarms are generated to notify the user in such cases.

Event Description

It was reported that during a surgery, when the oxygen concentration was set to 80%, the anesthesia workstation only provided an oxygen concentration level of approximately 40%.There was no report of patient harm reported.(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: 6025944
• MDR Text Key: 57695254
• Report Number: 8010042-2016-00466
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/13/2016
• 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