MAUDE Adverse Event Report: HEARTMATE II SYSTEM CONTROLLER, US, EP; VENTRICULAR (ASSIST) BYPASS

Model Number 103696

Device Problems Alarm Not Visible (1022); Electrical Power Problem (2925)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2024

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that there were low battery alarms at 14:00 and 19:00 (b)(6) 2024.Around 14:00, it was reported that the battery was switched to 14:50.When the low battery came out at 19:00, the patient reported that there was no alarm, and the power was not switched on.The patient's information and data were different.It seemed that power cable disconnect and low voltage advisory was recorded while the battery was connected.The patient was asymptomatic.Log files were submitted for review and displayed low battery advisories (including multiple power cable disconnects) while tethered on batteries as mentioned.There were no other unusual events seen within the log file.The mechanical circulatory support (mcs) equipment is operating as expected.

Event Description

It was reported that nothing was done to cause an alarm.The system controller was alarming appropriately, and no alarms were reported after the power module cable was replaced.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER, US, EP
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• MDR Report Key: 18988359
• MDR Text Key: 338730760
• Report Number: 2916596-2024-01883
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2021
• Device Model Number: 103696
• Device Lot Number: 6598026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 49 KG