MAUDE Adverse Event Report: MEDTRONIC / HEARTWARE, INC. HEARTWARE HVAD; VENTRICULAR (ASSIST) BYPASS

Device Problem Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2018

Event Type  Injury  

Event Description

Per incident report, "heartware hvad lvad battery charger is not charging batteries as expected in 2 of the 4 ports.Other 2 ports are functional at this time.Pt brought in battery charger serial #(b)(4) for replacement, this is the second time this has occurred.Pt states that no matter which batteries he plugs in the two right slots the indicator lights flash red and does not charge batteries.Pt provided with new battery charger serial # (b)(4) as a warranty replacement today.

• Brand Name: HEARTWARE HVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC / HEARTWARE, INC. ; 500 old connecticut path; framingham MA 01701
• MDR Report Key: 7832404
• MDR Text Key: 118933996
• Report Number: MW5079503
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 75