MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA

Catalog Number	107754
Medical Device Problem Codes	Loss of Power (1475); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the device was not provided, therefore the approximate age of device and manufacture date are not known.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016.A log file submitted to the manufacturer¿s technical services for analysis noted a no external power event recorded.This could be caused by the power cord of the mpu coming loose at the mpu or the wall outlet.Additional information was requested, but not provided.
Additional Manufacturer Narrative
Device evaluation: a specific cause for the captured event could not be conclusively determined through this evaluation.Evaluation of the submitted log file confirmed the reported no external power event on (b)(6) 2018 10:22 am while the lvad was connected to the mobile power unit (mpu).The associated voltage values indicated that these events appeared consistent with a loss of power to the mpu.This could have been caused by the ac power cord disconnecting from the back of the mpu, the power cord being disconnected from an outlet or loss of power to the home.The lvad system switched to the system controller backup battery and no interruptions in device therapy were captured.The event resolved upon reconnection to external power.No further related issues were reported.No other atypical events were captured within the log file and the remaining data showed normal device operation.Despite requests, no further information was provided.Technical services recommended the patient be provided a locking power cord if necessary.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
Section d4: the product's serial number was not provided by the customer.As a result, the product udi cannot be provided.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Common Device Name: MOBILE POWER UNIT
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7692983
• Report Number: 2916596-2018-02854
• Device Sequence Number: 16532701
• Product Code: DSQ
• UDI-Device Identifier: 00813024013006
• UDI-Public: 00813024013006
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 01/14/2019; 02/14/2019
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 02/04/2019; 02/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 77