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

Model Number FLOW-I C30

Device Problem Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  malfunction  

Event Description

It was reported that while the anesthesia workstation was connected to the patient, there were issues with the gas delivery during treatment start.There was no patient harm.Manufacturer's reference #: (b)(4).

Event Description

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

Manufacturer Narrative

The investigation of the reported failure has been completed.Based on the information collected to date, the provided problem description, inspection of the device and evaluation of the device logs, it has been clarified that there were issues during start of the treatment.The evaluation of the device logs showed that time range of the issue was between 10:11 and 10:21 (from the start of the treatment to the end).The treatment was started in automatic ventilation even though it was stated by the customer that the treatment was started in manual ventilation mode.According to the information provided from the customer, there were no flow of fresh gas to the patient.In consequence, multiple alarms were generated indicating a leakage situation.The log also shows multiple changes to the adjustable pressure level, used to set the pressure level in manual ventilation, which indicates that the user thought that the manual ventilation mode had been set.Before occurrence of the issue, system checkout (sco) passed.No entry in the technical log to indicate a system malfunction could be found.As the manual ventilation has not been chosen at the start of the case, the manual bag will not be filled up and will be non-functional.The type of ventilation, manual or automatic ventilation, is set with the man/auto switch.Except for the visible setting of the man/auto switch the chosen type of ventilation is also shown on the panel (user interface).According to the technician, the issue could not be reproduced, neither any part has been replaced to resolve it.The unit has been released for clinical use after the event occurred without further issues reported.There is no indication of a system malfunction at the time of the event but the true root cause has not been determined.The correction of field #h4 device manufacture date was required.This is based on the internal evaluation.#h4 manufacture date: previous manufacture date: 07/01/2018.Corrected manufacture date: 06/21/2018.

• 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: 11365186
• MDR Text Key: 233056685
• Report Number: 8010042-2021-00460
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2018
• 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