MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA; VENTRICULAR (ASSISST) BYPASS

Model Number	107754
Medical Device Problem Codes	Electrical Power Problem (2925); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient experienced multiple low voltage advisory alarms.Log file analysis showed several occurrences of no external power alarms while utilizing the mobile power unit as a power source.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event, of loss of external power alarms, was confirmed in the submitted log file.The customer submitted heartmate 3 lvas log files for review noting low voltage alarms.Technical service reviewed the log file and confirmed low voltage alarms associated with the loss of external power events while connected to the mpu.The event log file contained approximately 14 days of patient event data.There were multiple brief loss of external power events that occurred with the patient on the mpu.The events occurred over a 2 minute period.The controller operated on backup battery power due to the events.The mpu was the power source before and after the events.Multiple requests for additional event information were sent to the customer.No additional event information was reported.No product was returned for evaluation.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10187093
• Report Number: 2916596-2020-02943
• Device Sequence Number: 16996314
• Product Code: DSQ
• UDI-Device Identifier: 00813024013006
• UDI-Public: 00813024013006
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 107754OUS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 160