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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP CENTRIMAG MOTOR

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THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP CENTRIMAG MOTOR Back to Search Results
Model Number 102953
Device Problems Vibration (1674); Noise, Audible (3273); Excessive Heating (4030)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 07/01/2019
Event Type  Injury  
Manufacturer Narrative
Multiple attempts were made to obtain patient information however none was provided. 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 motor was warm and with a loud vibrating sound. Motor was exchanged.
 
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Brand NameCENTRIMAG BLOOD PUMP
Type of DeviceCENTRIMAG MOTOR
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 Key8778040
MDR Text Key150682447
Report Number2916596-2019-03231
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number102953
Device Catalogue Number102953
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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