inforMED
MalfunctionOBO

ZEISS CIRRUS HD-OCT 4000 RETINA TOMOGRAPHER

Received Sep 17, 2024 · Event occurred Sep 11, 2024

Report MW5159680 · MDR key 20246765

Device

Generic name

Tomography, Optical Coherence

Patient

68 YR · Female

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Narrative

Description of Event or Problem

ZEISS CIRRUS HD-OCT 4000 RETINA TOMOGRAPHER REPORTED INVALID RESULTS BASED ON OBVIOUS OUT OF RANGE MEASUREMENTS INCLUDING, FOR INSTANCE, AN AVERAGE RNFL (RETINAL NERVE FIBER LAYER) THICKNESS OF 40 UM, AN RNFL SYMMETRY OF "-5%", AND A CUP VOLUME OF 0.0000 MM^3. WITH OBVIOUSLY INVALID INPUTS, REPORTING RESULTS COULD CAUSE IMPROPER INTERVENTION BY THE CLINICIAN, UP TO AND INCLUDING SURGERY.