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

Model Number FLOW-I C20

Device Problem Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/12/2020

Event Type  malfunction  

Event Description

It was reported that while the anesthesia workstation was in use during a surgery, the patient did not saturate correctly.The doctors were not able to raise the saturation of the patient with use of the anesthesia workstation, therefore the doctor started to manually ventilate the patient.The patient was manually ventilated with an o2 cylinder.The patient desaturation level is unknown.(b)(4).

Manufacturer Narrative

The anesthesia workstation (hereafter refered to as the system) was investigated by our company field service engineer.No malfunctions were detected.The system worked as expected and no parts needed to be replaced.Information received from the user facility states that the lowest patient saturation level was 88 %.After the manual ventilation with o2 cylinder, the patient saturation level increased to 95 %, which is the same level as prior the event.The final patient outcome was no injury.The user facility didn¿t notice any malfunction on the device, the device was replaced as a precaution in an attempt to improve the patient situation.An evaluation of the received device logs show that system checkout prior to and after the event were successful and there were no technical alarms on the date of the event which indicate that there was no technical failure in the system during the event.After being set to hlm mode in the beginning of the case, the mode was changed to automatic ventilation and frequent alarms indicating a leakage were generated.The ventilation mode was changed between automatic and manual ventilation a few times and during the last 45 minutes of the case, manual ventilation mode was used.The apl pressure was set to sp during this time in manual ventilation.With the apl set to sp, the manual breathing bag slowly fills up to 2 cmh2o and the patient can breathe spontaneously.During this period in manual ventilation, alarms for fico2 high were generated on and off.The co2 absorber was not replaced during this time.The cause of the alarms indicating a leakage has not been determined.Except for this period with frequent alarms, there are no alarms indicating a flow or pressure delivery issue.Based on the on-site investigation , the information from the user facility and the log evaluation, our conclusion is that there was no technical failure in the system during the event.

Event Description

Manufacturer´s ref #: (b)(4).

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10223237
• MDR Text Key: 197275828
• Report Number: 8010042-2020-00382
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening