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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 106531INT
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2022
Event Type  malfunction  
Manufacturer Narrative
Related manufacturer report number 2916596-2021-04401. 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 patient's controller did not display after pushing the display button. No alarm occurred. Log files were uneventful. The controller was disconnected and reconnected to power module to troubleshoot. The controller was exchanged which resolved the issue. The patient was doing fine.
 
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Brand NameHEARTMATE 3 SYSTEM CONTROLLER
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key14239525
MDR Text Key290535341
Report Number2916596-2022-10632
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number106531INT
Device Lot Number7837610
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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