MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number C30

Device Problem Device Emits Odor (1425)

Patient Problem Forced Expiratory Volume Decreased (2430)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

The anesthesia workstation was investigated by the hospital personnel during the case.The ventilation problems were solved after a small nasogastric tube had been replaced for a larger one.Apart from the replaced nasogastric tube, no parts were replaced.No device malfunctions were found and the anesthesia workstation was returned back to clinical use where after it has been working according to specifications.The internal log from the concerned case shows that the reported issues started after the device was switched to prvc.Alarms such as: expiratory minute volume: low, etco2: low, airway pressure: high, regulation pressure limited and respiratory rate: high were generated shortly after the switch to prvc.Alarms for leakage were also generated.These alarms indicate insufficient ventilation and the alarm ¿regulation pressure limited¿ indicates that the tidal volume requested based on the settings could not be delivered within the maximum pressure level.This may have been caused by a too small nasogastric tube (which the user reported to have replaced for a larger one.It is not known at which time they replaced the small nasogastric tube for a larger one but it seems like the reported problems were reduced during the later part of the case.There are no indications of any device malfunctions and our conclusion is that the reported issues were caused by the use of a too small nasogastric tube.

Event Description

It was reported that during patient treatment, the staff had difficulties to ventilate the patient.A smell of anesthetic agent was reported and low expiratory volumes were measured.There was no patient harm.Manufacturer's ref: (b)(4).

• Brand Name: FLOW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 6600823
• MDR Text Key: 76405947
• Report Number: 8010042-2017-00250
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K133958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Date Device Manufactured: 12/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1