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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 201-90411
Device Problem Insufficient Information (3190)
Patient Problem No Patient Involvement (2645)
Event Date 03/27/2019
Event Type  Injury  
Manufacturer Narrative
No patient was involved.Age of device cannot be calculated at this time.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the console malfunctioned.The device was returning for evaluation.
 
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Brand Name
CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of Device
PRIMARY 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 Key8514960
MDR Text Key141954633
Report Number2916596-2019-01456
Device Sequence Number1
Product Code DWA
UDI-Device Identifier07640135140702
UDI-Public07640135140702
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number201-90411
Device Catalogue Number201-90411
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/27/2019
Initial Date FDA Received04/15/2019
Supplement Dates Manufacturer Received06/18/2019
Supplement Dates FDA Received06/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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