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

Device Problems Battery Problem (2885); Charging Problem (2892); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2021

Event Type  Injury  

Event Description

Equipment issue: patient reports connecting to battery a (sn (b)(4)) on port 1 this am, and battery indicator on hvad controller did not light up.Same on post 2.Battery displays full charge when unplugged from controller.Different battery in port 1 operates as expect.Affected equipment serial/lot number: sn (b)(4) new equipment supplied to patient: sn (b)(4).Equipment issue: patient brought hvad battery charger to clinic as 3rd port from left is having trouble when trying to connect batteries.On visual inspection, pin looks bent.Battery charger (b)(4) will be sent to medtronic for warranty exchange.Patient sent home with loaner #2 while awaiting battery charger shipment.Affected equipment serial/lot number: battery charger (b)(4) new equipment supplied to patient: patient provided hospital loaner while we wait for new battery charger patient has hvad.Fda safety report id # (b)(4).

• Brand Name: HEARTWARE HVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): MEDTRONIC INC
• MDR Report Key: 12058896
• MDR Text Key: 258627015
• Report Number: MW5102115
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• 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: 59 YR
• Patient Weight: 61