inforMED
InjuryFES

MODALITY POLYGRAPH SYSTEM

Received Feb 27, 1998 · Event occurred Feb 5, 1998

Report MW1013064 · MDR key 152928

Device

Generic name

Biliary Motility Machine

Model number

*

Catalog number

POS-81020C

Lot number

*

Product problems

  • Failure to Calibrate

Patient

40 YR

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

PT GIVEN SEDATION WHILE BILIARY MOTILITY MACHINE WAS BEING CALIBRATED. UNABLE TO CALIBRATE MACHINE. ERCP PROCEDURE CANCELLED DUE TO MACHINE NOT FUNCTIONING. VOLUNTARY REPORT FILE.