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

Model Number	FLOW-I C30
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia workstation generated alarm for regulation pressure limited during treatment.Alarm for high airway pressure was also generated.There was no patient harm.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported event has been completed.The system was tested by the hospital staff.The system checkout was successfully performed.The reported issue however remained in pressure regulated volume control (prvc) mode of ventilation during infant patient category cases.The system device logs were sent for evaluation together with pictures of the screen showing the flow and pressure graphs.The evaluation of the logs show, that the issue occurred several times.The trend log and also provided photo shows that the flow does not have time to become a decreasing flow before the inspiration phase was interrupted and turned over to expiration phase.Then during exhalation, the flow does not have time to be zero before the next breath begins.This indicates that there may have been a resistance in the breathing circuit.From the evaluation of logs and photo the conclusions were that the used breathing circuit, filters or hoses may have been damaged.It is unknown what breathing circuit that was used at the time of the event.The customer was suggested to try with another breathing circuit with same diameter.No further information was received from the customer how the issue was solved but the system has been put back for clinical use in working condition.The root cause to the reported issue has not been determined.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-I
• Common Device Name: 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: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 14495569
• Report Number: 8010042-2022-00903
• Device Sequence Number: 14907736
• Product Code: BSZ
• UDI-Device Identifier: 07325710010624
• UDI-Public: (01)07325710010624(11)210226
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FLOW-I C30
• Device Catalogue Number: 6888530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown