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

Model Number FLOW-I C30

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2022

Event Type  malfunction  

Event 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).

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 Description

Manufacturer's reference #: (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: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 15606158
• MDR Text Key: 304872513
• Report Number: 8010042-2022-01810
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 07325710010624
• UDI-Public: (01)07325710010624(11)210310
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: FLOW-I C30
• Device Catalogue Number: 6888530
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1