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
Manufacturer
Carl Zeiss Meditec, IncPatient
68 YR · Female
- Insufficient Information
- Insufficient Information
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.