FDA Adverse Event Malfunction Summary report: N

COMPAS2

MDR report key: 18939581 · Received March 20, 2024

Report

Report Number
18939581
Event Type
Malfunction
Date Received
March 20, 2024
Date of Event
February 14, 2023
Report Date
March 5, 2024
Manufacturer
MORGAN SCIENTIFIC, INC.
Product Code
BZG
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1132299 COMPAS2 SPIROMETER, DIAGNOSTIC BZG MORGAN SCIENTIFIC, INC. SOFTWARE VERSION 2022.2.1

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown