HEARTWARE CONTROLLER Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Ventricular Assist Device (LVAD)
Total Reports
4,810
Reports (30d)
0
Active Signals
0
Open Recalls
68
What the reports describe · Claripulse analysis
Most commonly reported problems
Controller Fault Alarm Due to Battery
backup battery, fault, controller exchanged, use, remains
7
reports
Power Cable Damage Causing Alarms
vad remains, assist device, ventricular assist, vad, device vad
3
reports
Damaged Controller Cable Nut
backup, controller exchanged, damage, connected, log file
1
reports
No External Power Alarm During Use
mobile, power unit, external power, mpu, mobile power
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Oct 31, 2023 · Open, Classified
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
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