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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 Problems No Display/Image (1183); Communication or Transmission Problem (2896); Electrical Power Problem (2925)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2022
Event Type  malfunction  
Event Description
It was reported that the patient's device alarmed for low voltages. The battery clips and mobile power unit were exchanged, but the alarms reoccurred and the screen disappeared from time to time. The controller was exchanged which resolved the alarms.
 
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
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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 Key13737222
MDR Text Key289322377
Report Number2916596-2022-01260
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeTW
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 05/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2021
Device Model Number106531INT
Device Lot Number6681018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2018
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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