MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA; VENTRICULAR (ASSISST) 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	06/05/2021
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 log file submitted revealed multiple no external power alarms.The patient stated they had been having power outages at home in their apartment building.The log file captured multiple no external power events on (b)(6) 2021 , (b)(6) 2021 , and (b)(6) 2021.The events on (b)(6) 2021 and (b)(6) 2021 were caused by power to the mobile power unit (mpu) being briefly interrupted due to the ac power cord coming loose at the mpu or ac wall outlet, or a house power disruption.The event on (b)(6) 2021 2021 appeared to have been the result of the patient simultaneously disconnecting power from both controller leads.There was no interruption in pump support during these events.The log file also noted a few low power hazards between (b)(6) 2021 and (b)(6) 2021 that were due to normal battery depletion.There were no other unusual events recorded in the log file event history.The equipment was operating as intended.Discussed results with patient and patient stated sometimes switching very quickly and the first battery may not be connected properly and may already moved on to the next one.Discussed precautions with patient.No additional information provided.
Additional Manufacturer Narrative
Manufactures investigation conclusion: the reported event of a no external power alarm was confirmed via the log files review.The log files spanned approximately 37 days (24may2021 to 30jun2021 per the timestamp).A no external power alarms activated on 05jun2021 at 08:57, 10jun2021 from 01:22 to 01:36 due to the rsoc voltage diminishing to ~2.6v.The backup battery was able to provide power to the pump during the alarm.The alarm resolved shortly after reconnecting to a power source.No other notable alarm was observed.The mobile power unit was not returned for analysis.Per provided information, the customer does not have the mpu serial number.The patient occasionally switches power sources very quickly and may not have been properly connected.The patient also experienced power outages at home.Multiple attempts were made to obtain additional information regarding the event; however, no response was received.A root cause of the reported event was determined to be power outages at home and possibly switching power sources very quickly.A review of the device history records revealed the device met applicable specifications.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Heartmate iii instructions for use (rev.A) section 7-¿alarms and troubleshooting¿ and heartmate iii patient handbook (rev.C) section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms including no external power.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: 12177932
• Report Number: 2916596-2021-03601
• Device Sequence Number: 16371059
• Product Code: DSQ
• UDI-Device Identifier: 00813024013006
• UDI-Public: 00813024013006
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 06/15/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 93