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

Model Number FLOW-I C30

Device Problem Output Problem (3005)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/14/2021

Event Type  Injury  

Event Description

It was reported that there was no co2 measured after the patient had been intubated.Anesthesiologists stated that the tube was seated correctly.The patient's saturation dropped and a switch to first a laryngeal mask was performed without improvement and then to an ambu bag and the patient's saturation increased.The final patient outcome was no injury.Manufacturer's reference #: (b)(4).

Event Description

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

Manufacturer Narrative

The anesthesia workstation (hereafter named system) was investigated on-site by the hospital biomedical engineer and our field service engineer.No fault found and no parts replaced.The gas analyzer calibration was performed without any deviations found.Measured co2 was correct and did not need to be calibrated.The system was returned for clinical use and no further issues have been reported.Additional information regarding the patient saturation level at the time of the event was requested but not received.The hospital had no more information to share.The test log shows that successful system checkout¿s were performed prior to and after the event.The technical log has no entry that would indicate a technical failure in the system at the time of event.The event log shows that the treatment was started at in manual ventilation and in adult patient category.No agent was set.O2 concentration was set to 100% and apl pressure set to 22 cmh2o.5 minutes after treatment start, the apl pressure was increased and the o2 flush button was pressed several times.The apl pressure settings was changed a number of times.The system was then set to automatic ventilation in prvc mode.Alarms for etco2 low, respiratory rate high, expiratory minute volume low, airway pressure high and regulation pressure limited were generated immediately.The set fresh gas flow and o2 concentration were decreased, but alarms were still generated.Function mac brain invalid - breathing circuit disconnected was logged and was followed by alarms for leakage, peep low and respiratory rate high, indicating that the patient was disconnected or there was a leakage.20 minutes after treatment start, the system was set to manual ventilation.The system was after this switched between automatic ventilation in prvc and manual ventilation 6 times and the o2 concentration was increased during this period.Alarms for expiratory minute volume low were generated every time automatic ventilation was used.About one hour after treatment start the system was set to standby and treatment ended.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.The root 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
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 12630498
• MDR Text Key: 276334207
• Report Number: 8010042-2021-02487
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

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 C30
• Device Catalogue Number: 6888530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening