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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 Problems Decreased Pump Speed (1500); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2019
Event Type  Injury  
Manufacturer Narrative
This report is against the centrimag console. The event is also reported against the centrimag motor in mfr. Report #2916596-2019-03600. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported there was a centrimag motor fail while the system was in use on a patient. The "motor failure" alarm message was displayed on the console while the rpms dropped from 4800 down to 3800. There were also no calculated flow readings. The motor and console were exchanged without any reported harm to the patient. Exchanging the system resolved the issue. No additional 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 Key8859643
MDR Text Key153231489
Report Number2916596-2019-03702
Device Sequence Number1
Product Code DWA
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 11/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model Number201-90411
Device Catalogue Number201-90411
Device Lot Number6515864
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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