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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: G - E CARESTATION 620 1A

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G - E CARESTATION 620 1A Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 12/09/2020
Event Type  Injury  
Event Description

Cardiac arrest during procedure.

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Brand NameG - E
Type of DeviceCARESTATION 620 1A
MDR Report Key11245115
MDR Text Key229420895
Report Number11245115
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2020
Distributor Facility Aware Date12/09/2020
Device Age1 mo
Event Location Hospital
Date Report TO Manufacturer12/14/2020
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Date Received: 12/15/2020 Patient Sequence Number: 1