inforMED
MalfunctionBZG

COMPAS2

Received Mar 20, 2024 · Event occurred Feb 14, 2023

Report 18939581 · MDR key 18939581

Device

Generic name

Spirometer, Diagnostic

Product problems

  • Computer Software Problem
  • Incorrect, Inadequate or Imprecise Result or Readings
  • Use of Device Problem

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

AN ISSUE WAS DISCOVERED WITH THE WAY THE COMPAS SOFTWARE CALCULATED RESULTS FOR LUNG DIFFUSION TESTS (DLCO). THE SOFTWARE PROMPTS THE RESPIRATORY THERAPIST TO 1) ACCEPT EFFORT, 2) EXCLUDE EFFORT OR 3) DELETE EFFORT. THE PULMONARY CLINIC LATER LEARNED THAT THE EXCLUDED EFFORTS WERE BEING INCLUDED IN THE CALCULATIONS IN THE VERSION OF COMPAS 2 THAT WAS IN USE FROM (B)(6) 2023 ¿ (B)(6) 2024. THE VENDOR RECENTLY UPGRADED THE COMPAS SOFTWARE IN (B)(6) AND THE CURRENT VERSION DOES NOT HAVE THIS ISSUE. A QUERY WAS RUN IN THE DATABASE THAT IDENTIFIED ABOUT 400 AFFECTED TESTS/PATIENTS. THE VENDOR MORGAN SCIENTIFIC CAN FIX THE TEST RESULTS RETROSPECTIVELY AND RE-CALCULATE THE RESULTS. THERE WILL BE SOME WORK TO RE-DO THE REPORTS AND REPLACE THEM, HAVE MDS RE-DO INTERPRETATIONS, ETC. ONCE RECALCULATED, ANY PATIENT IMPACTS WILL NEED TO BE IDENTIFIED AND ACTIONS TAKEN. THE VENDOR HAS NOT PROVIDED THE RECALCULATED DLCO TESTS TO DATE. MANUFACTURER RESPONSE FOR DLCO SOFTWARE, COMPAS2 (PER SITE REPORTER) THE VENDOR UPDATED THE SOFTWARE [REDACTED DATE]. THE VENDOR DID NOT NOTIFY THE CLINIC AT THE TIME OF THE SOFTWARE "GLITCH". THE HOSPITAL INQUIRED WHEN PROVIDERS WERE ASKING ABOUT UNEXPECTED RESULTS AT WHICH TIME THE VENDOR DISCLOSED THE GLITCH. WE ARE AWAITING THE RECALCULATED TEST RESULTS. AT WHICH TIME WE WILL ASSESS THE IMPACT ON EACH AFFECTED PATIENT.