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

Model Number	107754
Medical Device Problem Codes	Disconnection (1171); Loss of Power (1475)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date and age of device are unknown.Manufacturer's investigation conclusion: no product was returned to the manufacturer for analysis; however, low voltage and no external power alarms were confirmed based on the information recorded in the submitted system controller log file.Analysis of the data revealed that the low voltage levels occurred while the patient's lvad system was powered by a mobile power unit (mpu), and power to the mpu was lost.The pump support was not affected and the system was supported by the system controller's 11 volt lithium-ion backup battery.A cause for the loss of power to the mpu could not conclusively be determined.A review of the device history records could not be performed as the serial number of the device was not provided.No further information is available.The manufacturer is closing the file on this event.
Event or Problem Description
During investigation of the complaint, analysis of the submitted patient's system controller log file confirmed no external power events recorded on (b)(6) 2017.This could be caused by the power cord of the mobile power unit (mpu) coming loose at the mpu or the wall outlet.During these events the system controller¿s internal backup battery provided power to the pump as designed.Additional information was requested, but not 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: 7845017
• Report Number: 2916596-2018-03701
• Device Sequence Number: 19160877
• Product Code: DSQ
• UDI-Device Identifier: 00813024013006
• UDI-Public: 00813024013006
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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 Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 50