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

Model Number	107754
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient experienced a sudden red battery alarm with fully charged batteries.A series of no external power events occurred while connected to the mobile power unit (mpu) caused by power from the mpu being briefly interrupted.There was no interruption in pump support during these events.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of low voltage hazard and no external power alarms while connected to the mobile power unit (mpu) was confirmed via analysis of the submitted log.The submitted log file contained approximately 8 days of data ((b)(6) 2022 ¿ (b)(6) 2022 per the timestamp).The log file captured low voltage hazard and no external power alarms on (b)(6) 2022 from 16:26:11 to 16:26:13 and from 16:26:17 to 16:29:58 due to losses of external power while connected to the mpu.The system controller backup battery supported the system during the losses of external power without any issues.The alarms resolved each time once power to the system was restored.No other notable alarms were observed in the log file.The alarms did not affect the controller¿s ability to operate the pump at the set speed.The mpu was not returned for analysis.Multiple attempts were made to obtain additional information (including the serial number of the mpu, if the mpu has a v-lock connector on the ac power cord, if the ac power cord became loose from the back of the unit or from the outlet, if there were any environmental circumstances that would have affected ac power at the time of the event, and if the unit is currently operational); however, no response was received.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed, and the records revealed that the mobile power unit (mpu), serial number (b)(6), was manufactured in accordance with manufacturing and quality assurance 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: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15545682
• Report Number: 2916596-2022-14250
• Device Sequence Number: 5593385
• Product Code: DSQ
• UDI-Device Identifier: 00813024013006
• UDI-Public: 00813024013006
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American