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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; Pump, blood, cardiopulmonary bypass, non-roller type
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THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; Pump, blood, cardiopulmonary bypass, non-roller type Back to Search Results
Model Number 102956
Device Problems Pumping Stopped (1503); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2024
Event Type  malfunction  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the centrimag showed an e3 alarm code and the motor stopped for several seconds.The console and motor were sent back for investigation.Related mfr: 3003306248-2024-00416.
 
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Brand Name
CENTRIMAG MOTOR, US
Type of Device
Pump, blood, cardiopulmonary bypass, non-roller type
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
lindsey sallese
6035 stoneridge drive
pleasanton, CA 94588
7818528207
MDR Report Key18768982
MDR Text Key336546226
Report Number3003306248-2024-00417
Device Sequence Number1
Product Code KFM
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 Health Professional,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number102956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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