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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106762
Device Problems Electrical Power Problem (2925); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2021
Event Type  malfunction  
Manufacturer Narrative
The serial number of the controller has been requested but not yet provided. No further information was provided. A supplemental report will be submitted once the manufacturer's investigation is completed.
 
Event Description
It was reported that a broken black power connector that was unable to lock into a power source was noted. Several low power hazard events that occurred with the white power lead disconnected from power were noted in log file analysis, indicating that the connection at the black power lead had been compromised. Given the damage and older software version of the controller, it was recommended that the pocket controller be replaced.
 
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Brand NameHEARTMATE II SYSTEM CONTROLLER
Type of DeviceVENTRICULAR (ASSISST) 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 Key13308649
MDR Text Key284513596
Report Number2916596-2022-00290
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011286
UDI-Public813024011286
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number106762
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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