inforMED
MalfunctionMLO

PHILIPS HOLTER SOFTWARE

Received Jun 21, 2022 · Event occurred May 27, 2022

Report 1218950-2022-00504 · MDR key 14759288

Device

Generic name

Philips Holter Software

Model number

860292

Catalog number

860292

Product problems

  • Date/Time-Related Software Problem
  • Date/Time-Related Software Problem

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CUSTOMER REPORTED SOME OF THEIR STUDIES ARE NOT BEING CORRECTLY FLAGGED AS READ EVEN THOUGH THE DOCTOR IS READING THEM. FOR ONE STUDY, WHEN SEARCHING FOR A PATIENT STUDY TAKEN ON ONE DATE, A STUDY FOR A DIFFERENT DATE (SAME PATIENT) APPEARS AND VICE VERSA. A SECOND STUDY HAD ONLY THE LAST NAME OF THE PATIENT AND THE FIRST NAME WAS ADDED LATER. NO PATIENT HARM OR INJURY WAS REPORTED. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT.