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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
Model Number SERVO-I
Device Problem No Flow (2991)
Patient Problem Death (1802)
Event Date 01/18/2021
Event Type  Death  
Event Description

It was reported that the ventilator was connected to a patient at the time when the therapist set the ventilator to the standby mode while doing a patient circuit change. After the change the ventilator was not restarted to resume ventilation. The patient died. Manufacturer's ref. #: (b)(4).

 
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Brand NameSERVO-I
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
MDR Report Key11279879
MDR Text Key230295175
Report Number3013876692-2021-00010
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 02/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/04/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSERVO-I
Device Catalogue Number6487800
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2021
Distributor Facility Aware Date01/19/2021
Device Age5 yr
Event Location Hospital
Date Report TO Manufacturer02/04/2021
Date Manufacturer Received01/19/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/11/2015
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: 02/04/2021 Patient Sequence Number: 1
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