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

G - E; CARESTATION 620 1A

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Device Problem Insufficient Information (3190)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 12/09/2020

Event Type Injury

Event Description

Cardiac arrest during procedure.

1 Device was Involved in the Event
Brand Name	G - E
Type of Device	CARESTATION 620 1A
MDR Report Key	11245115
MDR Text Key	229420895
Report Number	11245115
Device Sequence Number	1
Product Code	BSZ
Reporter Country Code	US
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	User Facility
Reporter Occupation	Risk Manager
Type of Report	Initial
Report Date	12/12/2020
1 Patient was Involved in the Event
Date FDA Received	12/15/2020
Is this an Adverse Event Report?	Yes
Is this a Product Problem Report?	Yes
Device Operator	Health Professional
Was Device Available for Evaluation?	Yes
Is the Reporter a Health Professional?	Yes
Was the Report Sent to FDA?	Yes
Date Report Sent to FDA	12/14/2020
Distributor Facility Aware Date	12/09/2020
Device Age	1 MO
Event Location	Hospital
Date Report to Manufacturer	12/14/2020
Was Device Evaluated by Manufacturer?	No Information
Is This a Reprocessed and Reused Single-Use Device?	No
Type of Device Usage	N
Patient Sequence Number	1
Patient Outcome(s)	Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age	37 YR
Patient Weight	54