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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG PRIMARY CONSOLE INTERNAL BATTERY; Control, pump speed, cardiopulmonary bypass
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THORATEC SWITZERLAND GMBH CENTRIMAG PRIMARY CONSOLE INTERNAL BATTERY; Control, pump speed, cardiopulmonary bypass Back to Search Results
Model Number 104172
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2024
Event Type  malfunction  
Event Description
It was reported that there was a faulty battery.Once it was inserted into the console the console started alarming and the "battery module" appeared on the screen.The battery was swapped out and the console began working at normal.
 
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
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Brand Name
CENTRIMAG PRIMARY CONSOLE INTERNAL BATTERY
Type of Device
Control, pump speed, cardiopulmonary bypass
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 Key19100797
MDR Text Key340572373
Report Number3003306248-2024-00469
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K093832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/12/2024
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 Number104172
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/09/2024
Initial Date FDA Received04/12/2024
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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