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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE

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MAQUET CRITICAL CARE AB SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Catalog Number 6487800
Device Problems Display or Visual Feedback Problem (1184); Positioning Problem (3009)
Patient Problems Death (1802); Vomiting (2144)
Event Date 07/03/2017
Event Type  Death  
Event Description

It was reported that when invasive ventilation was started while the ventilator was connected to a patient, the co2 curve was displayed but there was no corresponding co2 value displayed on the screen. Because of absence of co2 value, the staff thought that the intubation was unsuccessful and tubing had been laid wrongly. Ventilation was stopped and the patient was extubated. After this extubation the patient vomited massively and died. (b)(4).

 
Manufacturer Narrative

The investigation has been completed. No parts were replaced. The field service engineer who was on site found no fault with the ventilator but loaded latest software version and the ventilator was returned to service. The logs did not cover the date of event but the course of events that was provided by the hospital and the software version of the ventilator suggest that the problem was software related. This occurrence is specific with the software version and in a specific order of occurrence which may lead to missing co2 curve and end tidal value (but not vco2 and vtco2 which are shown) when the ventilation type is changed from non-invasive ventilation (niv) to invasive ventilation after a disconnect situation. Co2 measuring is a monitoring function and does not affect delivered ventilatory values which will be as set. The conclusion in the matter is that the cause of the incident was the extubation/reintubation in a patient with reflux/aspiration. The absence of co2 curve and end tidal value could have contributed to the extubation/reintubation. This could possibly have been avoided if the positioning of the tracheal tube had been visually checked after the first intubation or if the vco2 and vtco2 displayed on the screen had been observed. A software update was implemented in march 2011 but the ventilator in this report had not been updated.

 
Event Description

Manufacturer reference#:(b)(4).

 
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Brand NameSERVO-I
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
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 Key6733642
MDR Text Key80706170
Report Number8010042-2017-00340
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK123149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6487800
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Ageyr
Event Location No Information
Date Manufacturer Received07/07/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/23/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/21/2017 Patient Sequence Number: 1
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