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 06/19/2020

Event Type  Injury  

Event Description

It was reported that the patient, with severe obesity, had good condition before being anesthetized, the measured oxygen saturation level was 94%.After induction and connection to the anesthesia workstation the measured oxygen saturation level was 86%.In the beginning after the induction the etco2 curve was not correctly displayed, the co2 curve had a flattened shape and the etco2 value was low.After a while it showed slightly better values.The oxygen saturation level was fluctuating between 80-89% with the patient having spastic breathing.The patient was moved to another device and the oxygen saturation increased to 92 %.There was no patient harm.Manufacturer´s ref #: (b)(4).

Event Description

Manufacturer´s reference#: (b)(4).

Manufacturer Narrative

Our field service engineer investigated the anesthesia workstation (hereafter named system) on-site.No fault was found.The system device logs were saved and sent for evaluation.The anesthesia workstation is back in clinical use without further issues.Evaluation of the received system device logs shows that the system checkouts performed prior to treatment start and after the event, were successful.There is no recording in the technical log that would indicate a technical failure in the system.The event log shows that after the successful system checkout in the morning, two treatment periods were performed without any issues.The treatment period where the event occurred, was started in manual ventilation mode with the apl set to sp during the first 10 minutes, this was probable during the introduction.With the apl set to sp the manual breathing bag is being filled up slowly up to 2 cmh2o apl pressure and the patient can breathe spontaneously.The o2 concentration was set to 100 % o2 and the lower etco2 alarm limit was set to 4 kpa.The apl was then increased to 47 cmh2o and an agent concentration was set.An alarm for etco2 low was generated.A minute later, automatic ventilation in volume control was started and alarms for airway pressure high and etco2 low were immediately generated.After only 20 seconds, the ventilation mode was set back to manual ventilation and the apl was set to 35 cmh2o.The o2 flush button was pressed several times.The alarm for etco2 low was generated.After three minutes in manual ventilation mode, automatic ventilation in volume control was started again.Alarms for airway pressure high, etco2 low, expiratory minute volume low and respiratory rate high were generated.After only 20 seconds, manual ventilation was started again.The treatment in manual ventilation was ongoing during 20 minutes until the system was shutdown by the user.The o2 flush was frequently used and a few alarms for etco2 low and etco2 high were generated during the time in manual ventilation.The alarms generated, the switching between ventilation modes and the frequently used o2 flush indicates that there were issues to get the ventilation to work.Our conclusion is that there were no technical system malfunctions at the time of the event.The system detected and properly alarmed for the reported issues.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10243983
• MDR Text Key: 197911924
• Report Number: 8010042-2020-00409
• 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: 10/16/2020

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 C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening