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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE Back to Search Results
Model Number 201-30300
Device Problem Visual Prompts will not Clear (2281)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2019
Event Type  Injury  
Manufacturer Narrative
Reference mfr medwatch report # 2916596-2019-00417 for the submission on the motor. The primary console is not a single use device. Approximate age of the device will be provided with the device evaluation results. The device is expected to be returned for evaluation. It has not yet been received. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that during an extracorporeal membrane oxygenation (ecmo) procedure, the console indicated a system alert (s3) alarm. The healthcare professional pressed the alarm acknowledgement button but alarm did not resolve. The console and motor were exchanged to the backup equipment. No further information was provided.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of DevicePRIMARY CONSOLE
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key8295504
MDR Text Key134744906
Report Number2916596-2019-00533
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30300
Device Catalogue Number201-30300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/12/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/01/2019 Patient Sequence Number: 1
Treatment
MOTOR, SERIAL # (B)(4)
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