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

Model Number	FLOW-I C30
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The anesthesia workstation 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).
Additional 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.
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
• MDR Report Key: 9223969
• Report Number: 8010042-2019-00779
• Device Sequence Number: 13604836
• Product Code: BSZ
• UDI-Device Identifier: 07325710001363
• UDI-Public: (01)07325710001363(11)171009
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K160665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: FLOW-I C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Weight: 90