MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB O2/AIR MIXER 965; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Catalog Number 9341173

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation was performed by the biomedical engineer at the hospital.The biomed concluded that there was no malfunction on the ventilator system side, as the issue had been present independent of different connected ventilator systems.The issue could not be reproduced during testing of the ventilator system.The gas system was checked by the air gas company and the ballasts were replaced, all was found to be within expected specification.The biomed further stated that an o2-air mixer (oxygen blender) was set in line on the main gas line to the ventilator.The oxygen blender had not been checked annually.The oxygen blender has now been serviced by the hospital facility.According to the user manual for the oxygen blender, this device shall be technically checked four times a year or twice a year if the oxygen blender is protected by efficient filters at the gas inlet and o2 concentrations is continuously monitored.If the oxygen blender does not operate satisfactory, it must not be used.It has not been confirmed if any parts were replaced or found faulty on the oxygen blender during the service.Service must be carried out once a year by a maquet authorized personnel.Our final conclusion is, that the issue might be traced to the device oxygen blender, but no final root cause has been identified.

Event Description

It was reported that during patient treatment there were intermittent discrepancies between set fio2 and analyzed fio2 on the ventilator.There was no patient harm reported.(b)(4).

• Brand Name: O2/AIR MIXER 965
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• 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: 6416704
• MDR Text Key: 70557859
• Report Number: 8010042-2017-00115
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• PMA/PMN Number: K872278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/20/2017

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 Catalogue Number: 9341173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/20/2017
• 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