MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number C30

Device Problems Inflation Problem (1310); Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 03/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a few minutes after start of a case with the anesthesia workstation, the patient saturation level suddenly began to fall.The patient saturation level decreased to 35% according to the patient monitoring system.The user description of the event states that after induction, the patient was connected to the anesthesia workstation and manually ventilated.Appropriate ventilation was confirmed with end tidal carbon dioxide measurement.Suddenly the saturation began to fall rapidly.The screen displayed a measured value of fio2 being at only 9%.The anesthesia workstation built in emergency ventilation was started but the manual breathing bag didn¿t inflate properly.The patient was disconnected from the anesthesia workstation and was bagged and the patient¿s saturation recovered.The final patient outcome was no injury.(b)(4).

Manufacturer Narrative

The anesthesia workstation was investigated on site by the hospital biomedical department.No fault was found and no parts were replaced.The device logs were saved and sent for evaluation.Evaluation of the log shows that system checkout (sco) prior to and after the event passed without deviations.The case was started in automatic ventilation and after 20 seconds set to manual ventilation.No alarms, parameter changes or other user activities were logged during 3 minutes.After 3 minutes, alarm for fio2 low was generated and 20 seconds after that the anesthesia workstation's built in safety flush was activated due to fio2 was measured low.The log shows that measured fio2 was 9.5 %.Less than a minute later the anesthesia workstation was shutdown; the emergency ventilation was started.The anesthesia workstation was restarted after 30 minutes and a successful sco was performed.The anesthesia workstation was shutdown after the sco.No technical errors are logged at the time of the event.The trend log that contains the measured parameter values is not available.There is no indication in the logs of a technical failure in the anesthesia workstation at the time of the event.Our conclusion, based on the logs and that no fault was found with the anesthesia workstation, is that there was no technical failure in the anesthesia workstation that caused the reported event.The true root cause of the event has not been determined.(b)(4).

Event Description

(b)(4).

• Brand Name: FLOW-I C30
• 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: 7402969
• MDR Text Key: 104571607
• Report Number: 8010042-2018-00175
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2011
• 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