MAUDE Adverse Event Report: HEARTWARE HVAD; LEFT VENTRICULAR ASSIST DEVICE

Device Problems Pumping Stopped (1503); Charging Problem (2892)

Patient Problem No Information (3190)

Event Date 03/14/2018

Event Type  Injury  

Event Description

Pt at home and noted issues with irregular battery charge and use and with pump stop alarms.Notified the lvad team and was instructed to come in to clinic.Six batteries and her primary controller were replaced on (b)(6) 2018 by the heartware hvad company.

• Brand Name: HEARTWARE HVAD
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• MDR Report Key: 7778406
• MDR Text Key: 117019544
• Report Number: 7778406
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Report Sent to FDA: 08/07/2018
• Distributor Facility Aware Date: 03/14/2018
• Device Age: 2 YR
• Event Location: Home
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 150