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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 Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Cyanosis (1798); Sweating (2444); Low Oxygen Saturation (2477)
Event Date 03/15/2016
Event Type  Injury  
Event Description

On 04/08/2016 09:27 am (gmt-4:00) added by (b)(6): it was reported that while the ventilator was connected to a patient, it was observed that the patient was cyanotic and sweating. The saturation had dropped to 66% at approximately 7:40 a. M. The anesthetic doctor was called, at this time it was discovered that the ventilator was in the standby mode and not ventilating. Ventilation was then restarted. The final patient outcome was no injury. (b)(4).

 
Manufacturer Narrative

On discovery that the ventilator was in the standby mode, ventilation was re-started whereas the ventilator functioned without problems. Later on, after removal from service, the ventilator was examined by the hospital staff and no problems were found. The ventilator's logs were downloaded, no parts were replaced, and the ventilator was returned to service. The investigation therefore consists of an evaluation of the logs and information that was received from the hospital. The evaluation of the logs showed that at the time of the event, ongoing ventilation was stopped, and the ventilator was actively set to the standby mode by the user. It was left in this state for about 16 minutes. The entries during this action showed that the setting was user induced. There is nothing in the logs to indicate that there was a ventilator malfunction at the time. Our conclusion in this matter is, that there was no ventilator malfunction at the time. The cause for the event was the setting of the ventilator into the standby mode and leaving it in this state for 16 minutes. When the ventilator is in the standby mode, it does not ventilate, the word ¿standby¿ text is clearly visible on the user interface. The cause for the event is attributed to user error. Leaving the ventilator in the standby mode while it is connected to patient, who is in need of ventilator therapy, means that the patient is not ventilated which could lead to desaturation.

 
Event Description

(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 Key5563067
MDR Text Key42333824
Report Number8010042-2016-00202
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeNO
PMA/PMN NumberK123149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 03/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6487800
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/20/2009
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: 04/08/2016 Patient Sequence Number: 1
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