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

Model Number FLOW-I C30

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 10/11/2019

Event Type  Injury  

Event Description

The anesthesia work station was connected to a patient and the treatment was running in automatic ventilation with automatic gas control (agc) selected.The anesthetic agent was delivered in the beginning of the treatment but after change from sevoflurane (vaporizer in slot 1) to desflurane (vaporizer in slot 2) the agent delivery stopped.This was detected after 41 minutes and the system was after that set to manual gas control with sevoflurane vaporizer in slot 1 selected and agent delivery started.The patient awareness level increased and this was indicated by blood pressure and increased respiratory rate.No reported psychological harm.The patient has been discharged.Manufacturer's reference #: (b)(4).

Event Description

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

Manufacturer Narrative

This foreign complaint was reported based on the available information at the time.The investigation has however determined that the cause of the event is related to a specific sw version.This sw version is not released and will not be released on the us market, therefore no units on the us market are affected.This complaint does therefore not meet the reporting criteria for mdr and should not have been reported.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9226459
• MDR Text Key: 163896139
• Report Number: 3013876692-2019-00025
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 07325710001363
• UDI-Public: (01)07325710001363(11)171009
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FLOW-I C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2020
• Distributor Facility Aware Date: 03/27/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 90