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

Model Number FLOW-I C20

Device Problem Output Problem (3005)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/15/2020

Event Type  Injury  

Event Description

It was reported that during patient treatment, the anesthesia workstation did not deliver the correct concentration of oxygen and alarms for low fio2 were generated.It was further reported that there was a temporary drop in the patient's saturation level.There was no serious patient outcome.Manufacturer´s ref #: (b)(4).

Event Description

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

Manufacturer Narrative

Additional information received from the anesthetist at the hospital states that the patient lowest saturation level was about 80 %.The patient recovered to the same level as before the event, 96 %.Our field service engineer investigated flow-i on-site.The system checkout was successfully performed, function test with different o2 concentrations set (21%, 40%, 80% & 100%) was without deviations and gas analyzer calibration also passed without deviations.No fault was found and no parts were replaced.The event log confirms the alarms for fio2 low on three occasions and shows also that alarms for etco2 low and high respiratory rate were generated.The case was ongoing during 49 minutes.The case was started in manual ventilation with o2 concentration set to 80 % and apl set to sp.(with the apl set to sp the manual breathing bag fills slowly up to 2 cmh2o apl pressure and the patient can breathe spontaneously.) the o2 concentration was then increased to 100 % and 1.5 minute after the case start, an alarm for fio2 low was generated.One minute after the first alarm, the second alarm for fio2 low was generated and the user activated the o2 flush and increased the apl to 21 cmh2o.After a few minutes, the user switched to automatic ventilation during 30 seconds and then back to manual ventilation.After this, several switches between manual and automatic ventilation were performed during 15 minutes.The third alarm for fio2 low was generated during these switching between the ventilation modes.The last 30 minutes of the case was in manual ventilation.The many switches between manual and automatic ventilation indicate that there were issues with the ventilation.The etco2 low alarms may indicate that the patient was not sufficient ventilated.The test log shows that system checkout prior to and after the event was successful and the technical log has no entry in the log on the date of the event which indicates that there was no technical failure in the system.The trend log is missing and therefore the measured level of fio2 cannot be confirmed.Based on the investigation on-site and the log evaluation the conclusion is that there was no technical failure in the system at the time of the event.The cause of the reported event has not been determined.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9627367
• MDR Text Key: 188494892
• Report Number: 3013876692-2020-00006
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2020
• Distributor Facility Aware Date: 01/24/2020
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2020
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other