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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 Activation Failure (3270)
Patient Problem Death (1802)
Event Date 02/19/2021
Event Type  Death  
Event Description

The following was reported: ventilator found to be in standby mode at beginning of case. Unable to activate ventilation mode. Ambu bag ventilation started. Respiratory called - code called. Severe 3 vessel disease. Patient placed on balloon pump: impella placement. Biomed has the ventilator in house - to contact the company per biomed for evaluation recommendations.

 
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Brand NameSERVO-I
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
45 barbour pond drive
wayne NJ 07470
MDR Report Key11403914
MDR Text Key234420444
Report Number11403914
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 02/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberSERVO-I
Device Catalogue Number6487800
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2021
Event Location Hospital
Date Report TO Manufacturer03/03/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/03/2021 Patient Sequence Number: 1
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