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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE POWER MODULE VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE POWER MODULE VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1340
Device Problems Fracture (1260); Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Event Description
It was reported that power module had a cracked casing; the unit was sent in for repair.
 
Manufacturer Narrative
There was no patient involved in this event. The pma number provided is associated with most recent approval. No further information was provided. A supplemental report will be submitted once the manufacturer's investigation is complete.
 
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Brand NameHEARTMATE POWER MODULE
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 Key12924083
MDR Text Key285855434
Report Number2916596-2021-06661
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
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,Followup,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1340
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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