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CARDIOMEMS PATIENT ELECTRONIC SYSTEM Adverse Event — Malfunction (MDR 3004936110-2020-00198)

CARDIOMEMS PATIENT ELECTRONIC SYSTEM Adverse Event — Malfunction (MDR 3004936110-2020-00198) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CARDIOMEMS PATIENT ELECTRONIC SYSTEM; Generic name: SYSTEM, HEMODYNAMIC, IMPLANTABLE; Manufacturer: ST. JUDE MEDICAL, INC..

DeviceCARDIOMEMS PATIENT ELECTRONIC SYSTEM
Generic nameSYSTEM, HEMODYNAMIC, IMPLANTABLE
ManufacturerST. JUDE MEDICAL, INC.
Report number3004936110-2020-00198
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, CONSUM
NarrativeDURING DEVICE ANALYSIS, THE REPORTED ERROR WAS TRACED TO AN INCORRECT SPEED SETTING OF THE COMPACT FLASH.
SourceopenFDA MAUDE (device adverse events)

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