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

Model Number C20

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

Event Description

It was reported that while using the anesthesia workstation on a patient, a lower oxygen concentration than set was measured.There was no patient harm.(b)(4).

Manufacturer Narrative

The replaced oxygen gas module was returned together with a complete set of device logs no damages or deviations were found during a visual inspection of the returned gas module.The gas module was tested i a reference machine but the reported issue with the oxygen concentration not being measured according to settings has not been reproduced during this investigation.The tested oxygen gas module worked as intended during the 4 days long test period.An evaluation of the received device logs show that no technical alarms were generated during the event.The logs show that the fio2 level was lower than set at some points but the measured fio2 value and set o2 concentration are not expected to match at all times in an anesthesia machine in manual gas control mode (mgc) since when there is a certain amount of gas that is being re-breathed via the 1,2 liter large volume reflector (the tidal volume was around 80ml) it takes time for the oxygen concentration to stabilize and that is probably why the customer reacts to the ¿lower fio2¿ than set.Based on the investigation of the returned o2 gas module and the evaluation of the device logs, our conclusion into this matter is that the experienced "lower fio2 than set" was not caused by a device malfunction.

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: 6770361
• MDR Text Key: 82072916
• Report Number: 8010042-2017-00363
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• 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
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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