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

Model Number FLOW-I C40

Device Problem Output Problem (3005)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the anesthesia workstation failed in several subtests during system checkout.There was no patient involvement.Manufacturer's reference #: (b)(4).

Manufacturer Narrative

Investigation of the reported event has been completed.Our field service engineer investigated the system and the reported failure was reproduced.The issue was solved by replacing o2 and air gas modules, two pressure transducer printed circuit boards (pcb) and the double channel plate.No parts have been returned for the further analysis of the issue.Evaluation of the received device logs confirmed the reported issue.The pressure transducer test failed due to that the measured zero pressure offset for the fresh gas pressure transducer had drifted outside acceptable limits.The flow transducer test failed due to that no flow were measured from the air/o2 gas module.The air/o2 gas module regulate the air/oxygen gas flow and a fault in the air/o2 gas module may lead to inaccurate gas flow regulation.The pressure transducer pcb is part of the pressure measuring in the system.A faulty pressure transducer pcb may lead to inaccuracy in pressure measurement.This will be detected during sco and alarms will be activated if the failure occurs during treatment.The root cause to the reported issue 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: 06/24/2011; corrected manufacture date: 06/27/2011.

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: 11372426
• MDR Text Key: 233281465
• Report Number: 8010042-2021-00479
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C40
• Device Catalogue Number: 6677400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2011
• 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