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 No Consequences Or Impact To Patient (2199)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

It was reported that during patient treatment, there were issues with providing gas to the patient.Alarms for high airway pressure were generated.There was no patient harm.Manufacturer´s ref #: (b)(4).

Manufacturer Narrative

The logs from the anesthesia system were downloaded and the patient cassette was replaced.The patient cassette was sent for investigation together with the device logs.An evaluation of the received logs revealed that a deficit between tvi and tve seems to correspond to a sudden drop in cdyn.The deficit ends at the end of the case approximately the same time the cdyn increases again.The decrease of cdyn indicates that the transpulmonary pressure has increased which forces the anesthesia system to use higher pressures to deliver the set tidal volume.An increase in ppeak could trigger a leakage in the airway interface resulting in the described difficulties with ventilating the patient.The technical log has no recordings related to the reported leakage issues.The test log has no failing sco tests.The trend log has no data since the log was saved too late.The returned patient cassette was long term tested in ventilation mode in a reference anesthesia system.The reported fault could not be reproduced.Several successful system check outs were performed both prior to and after the long term testing.We have not been able to determine the true cause of the reported event.

Event Description

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

• 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: 11281156
• MDR Text Key: 230453183
• Report Number: 8010042-2021-00259
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1