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

Model Number	107754
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient¿s weight was not provided.The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date and age of device are unknown.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) 2018.It was reported that the manufacturer¿s technical services representative reviewed the submitted log file and during the analysis of the log, it was reported that a low power hazard alarm was observed on (b)(6) 2018 which may be due to the mobile power unit (mpu) ac power cord coming loose at the ac power cord mpu connection or ac wall outlet.There was no interruption in pump support to the patient during this event.No additional information was provided.
Additional Manufacturer Narrative
The mobile power unit (mpu) was not returned for analysis and remains in use.Although the evaluation of the submitted system controller log file confirmed a no external power event, a specific cause for this event could not be conclusively determined through this evaluation.The system controller log file contained approximately 11 days of data from (b)(6) 2018 at 21:13:42 through (b)(6) 2018 at 13:21:39, per time stamp.The file captured a no external power event on (b)(6) 2018 at 06:32:04.A sequence of low power hazard and power cable disconnect alarms were observed.This event occurred while the controller was supported by an mpu and appeared to be a result of momentary power loss to the mpu.During this event the controller supported the pump at the set speed while being powered by the internal backup battery, as designed.Once ac power was restored to the mpu at 06:32:09, all the associated alarms cleared.No other atypical alarms were recorded in the remaining events and the pump operated at the set speed throughout the log file.Multiple requests for additional information regarding the event, including the mpu serial number, were issued to the customer; however, no further information has been provided to this date.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• 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: 7793790
• Report Number: 2916596-2018-03146
• Device Sequence Number: 228097
• Product Code: DSQ
• UDI-Device Identifier: 00813024013006
• UDI-Public: 00813024013006
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/14/2019

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 Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 02/08/2019; 02/18/2019
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 12/05/2018; 02/21/2019; 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR