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GE VINGMED Adverse Event — Malfunction (MDR MW5005580)

GE VINGMED Adverse Event — Malfunction (MDR MW5005580) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: GE VINGMED; Generic name: TRANSESOPHAGEAL ULTRASOUND PROBE; Manufacturer: GE.

DeviceGE VINGMED
Generic nameTRANSESOPHAGEAL ULTRASOUND PROBE
ManufacturerGE
Report numberMW5005580
Event typeMalfunction
Product problemY
Date received2008-02-15
NarrativeOUTPT HAVING TEE PERFORMED TO EVALUATE ECHODENSE MASS ON ANTERIOR LEAFLET OF MITRAL VALVE; TEE PROBE STOPPED WORKING 10 MINS AFTER START OF STUDY -WHILE IN PT'S ESOPHAGUS-. PROBE WAS CHECKED AND CALIBRATED PRIOR TO PROCEDURE; ATTEMPTS AT RECALIBRATING PROBE UNSUCCESSFUL. PROBE REMOVED AND PROCEDURE STOPPED UNTIL NEW PROBE OBTAINED WHICH RESULTED IN 10 MIN DELAY IN PROCEDURE BUT NO HARM TO PT, WHO
SourceopenFDA MAUDE (device adverse events)

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