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

Model Number FLOW-I C20

Device Problem Output Problem (3005)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

It was reported that during patient treatment, the anesthesia system generated alarms for high airway pressure and alarms indicating an issue with the pressure measurment.There was no patient harm.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The investigation of this complaint has been completed.The anesthesia system was investigated on-site by our field service engineer.The investigation revealed that one of the pressure transducer pcb's in the system was faulty, it was replaced which solved the reported failure.The replaced part was not returned for investigation.Evaluation of the received system device logs confirmed the reported failure.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 system checkout and high priority alarms will be generated if the failure occurs during treatment.Our conclusion is that the reported failure was caused by a faulty pressure transducer pcb.

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: 15208123
• MDR Text Key: 302508187
• Report Number: 8010042-2022-01366
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• 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?: Yes
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose