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

Model Number C20

Device Problem Improper Flow or Infusion (2954)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/16/2017

Event Type  Injury  

Event Description

It was reported that during patient treatment, the minute volume would slowly decrease and the patient desaturated.The patient was ventilated manually where after the patient's saturation level went back to normal.There was no permanent patient harm reported.(b)(4).

Manufacturer Narrative

The returned anesthesia workstation has been simulated use tested in our laboratory environment.The reported issues with decreasing volumes have not been reproduced.The anesthesia workstation has been tested in different ventilation modes with different settings including settings made during the reported issue.The technical log does not have any recordings.The test log contains only successful system check outs (sco) including the sco performed on the morning prior to the reported event.The received logs have been evaluated both by our local application specialist as well as our in-house clinical experts.According to the trend log, the issues with a lower minute volume occurred on three occasions.During all of these three occasions, pressure control mode was used.The set pressure level above peep was 10cmh2o during all three occasions and the logs show further that the user never changed the pc above peep level even though mvi, tv, and cdyn gradually decreased over time during these three occasions.At the end of the three occasions, the operator switched ventilation mode to manual ventilation and since they are using afgo as manual ventilation mode.The experienced decrease in volumes, flow and cdyn (cdyn = dynamic compliance) are most likely related to the user not changing the pressure level above peep based on the actual condition of the patient at that time.Our conclusion is that there were no malfunctions of the anesthesia workstation during the reported time period.

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: 7002973
• MDR Text Key: 91084596
• Report Number: 8010042-2017-00539
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2014
• 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
• Patient Outcome(s): Life Threatening