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

Model Number FLOW-I C30

Device Problem Infusion or Flow Problem (2964)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/27/2019

Event Type  Injury  

Event Description

It was reported that the patient was not being properly ventilated while the anesthesia workstation was connected to the patient.The patient saturation level decreased and the ventilation mode was changed to manual ventilation.In manual ventilation only a small volume was possible to give for each compression of the manual bag and it felt like there was a ¿mechanical stop¿.The patient was disconnected from the anesthesia workstation and was further ventilated with a manual resuscitator.It is not known to what level the patient saturation decreased.Manufacturer's reference #: (b)(4).

Event Description

Manufacturer's reference #: (b)(4).

Manufacturer Narrative

The user facility did not request any service or investigation of the anesthesia system.No more information about the event or patient final outcome has been received.The system has been returned for clinical use without further issues reported.No information about replaced parts has been received.The system device logs and some pictures of the screen showing the flow and pressure curves from the time of the event were received for evaluation.Evaluation of the device logs show that the case was started in manual ventilation and after about 15 minutes set to automatic ventilation.During the first minutes in automatic ventilation, a few alarms for airway pressure high were generated that ceased after the pressure parameter setting was changed.After about 30 minutes in automatic ventilation, several alarms for respiratory rate high and expiratory minute volume low started to be generated and then also one alarm for leakage.The combination of these alarms indicate a leakage situation.The system was switched between automatic and manual ventilation on two occasions.The alarms for respiratory rate high and expiratory minute volume low re-occurred in automatic ventilation.The case was ended by the user.A complete system checkout was performed in the morning on the date of event which passed without deviations.Prior to the case start, a leakage check was successfully performed.No system checkout was performed after the case and before the system device logs were saved.There is no technical error in the log that would indicate a technical failure in the system.An evaluation of the received pictures shows that extra breaths were triggered.The pressure curve shows that the measured airway pressure was according to the pressure parameter settings.The breaths that were triggered was most probable caused by a possible leakage.A self-triggering (auto-cycling) condition may be reached if there is leakage in the breathing circuit.Triggering will then be initiated by the system and not by the patient.Based on the information that the system is back in clinical use, no parts were replaced, no service on the system was requested, logs and pictures show no indication of a technical failure in the system, our conclusion is that there was no technical malfunction in the system at the time of the event.The system generated alarms according to user settings.We have not been able to determine the cause of the reported event.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9207811
• MDR Text Key: 162816611
• Report Number: 8010042-2019-00760
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K160665
• 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: 01/30/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: FLOW-I C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening