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

Model Number	FLOW-I C30
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia workstation shows low tidal volume and low exhalation co2 concentration.There was no patient harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
Based on the information collected to date, the provided problem description and the inspection of the device conducted by the technician, it has been clarified that the initially claimed malfunction, has not been reproduced.The technician performed all tests and put back the device in working condition.The device's logs has been evaluated.The treatment was ongoing for 30 minutes.The following alarms indicating a leakage were generated from start: expiratory minute volume low, respiratory rate high, etco2 low and fico2 high.The combination of alarms generated indicates a leakage situation and this may affect the co2 measuring.The test log shows that system checkout (sco) prior to the events passed without deviation.The first sco performed after the event passed without issues.The technical log has no recordings on the date of event, which indicates that there was no technical failure in the device at the time of the event.The root cause to the reported issue has not been determined, however there is no indication of a technical failure in the system.The correction of fields #d4 catalog #, #h4 device manufacture date and #h8 usage of device was required.This is based on the internal evaluation.#d4 catalog #: previous catalog #: 6677300, corrected catalog #: 6888530.#h4 manufacture date: previous manufacture date: 03/18/2021, corrected manufacture date: 03/10/2021.#h8 usage of device: previous usage of device: unknown.Corrected usage of device: reuse.
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: 15606158
• Report Number: 8010042-2022-01810
• Device Sequence Number: 19350933
• Product Code: BSZ
• UDI-Device Identifier: 07325710010624
• UDI-Public: (01)07325710010624(11)210310
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 09/19/2022
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown