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

Model Number FLOW-I C20

Device Problem Incorrect Measurement (1383)

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

Event Date 12/15/2022

Event Type  malfunction  

Event Description

It was reported that while the anesthesia workstation was in use, there was a difference in measured/showed peak pressure compared to the the actual peak pressure.Furthermore high airway pressure alarm has been found in provided log files.There was no patient harm.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

Investigation of the reported event has been completed.According to provided information, the failure could not be reproduced on site.The system was returned for clinical use and no similar problems have been reported after the reported event.Evaluation of the received device logs can confirm the reported high airway pressure alarm in volume control mode of ventilation.In pressure control mode of ventilation there was no alarms generated and the log shows that the measured peak pressure followed the set pressure.The system checkouts performed prior to and after treatment start were successful.There is no indication of a device malfunction.The root cause of the reported problem has not been determined.

Event Description

Manufacturers ref: #(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: 16076647
• MDR Text Key: 306495238
• Report Number: 8010042-2022-02345
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2022

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 C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1