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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE POWER MODULE; VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number L1340
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2023
Event Type  malfunction  
Manufacturer Narrative
There was no patient involved in this event.The pma number provided is associated with most recent approval.Manufacturer's investigation conclusion: the reported event of a broken shell/case was confirmed upon arrival of the returned power module (serial number: (b)(6)).Visual inspection of the unit revealed that the top housing, bottom housing, handle overlay, and one rubber foot were cracked broken.The damaged components were replaced.It was also noted that the battery clip was damaged.Preventative maintenance was performed, and the serviced power module then passed a full functional checkout and was found to perform as intended.The root cause of the observed damages cannot be conclusively determined through this investigation.Review of the device history record for the power module, serial number: (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate power module instructions for use (ifu) (rev.B) instructs users to regularly inspect the power module, and to not use a power module that appears damaged.The heartmate power module ifu (section 11.0 ¿routine maintenance¿) instructs users to bring their power module to an authorized service technician at least once per year for a thorough inspection and cleaning.The heartmate 3 patient handbook (rev.D) cautions the user to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
 
Event Description
It was reported that power module had a broken shell and case.Evaluation found the battery clip was also damaged.
 
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Brand Name
HEARTMATE POWER MODULE
Type of Device
VENTRICULAR (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
lindsey sallese
6035 stoneridge drive
pleasanton, CA 94588
7818528207
MDR Report Key18761952
MDR Text Key336920796
Report Number2916596-2024-01211
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 Other,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberL1340
Device Lot Number5795458
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2023
Was the Report Sent to FDA? No
Date Manufacturer Received02/20/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2012
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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