BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1077 MADSEN ACCUSCREEN, ABR/DP

    MDR report key: 16277321 · Received February 1, 2023

    Report

    Report Number
    9612197-2023-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Report Date
    December 5, 2023
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    GWJ
    PMA / PMN Number
    K122067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCUSCREEN / GETTING FALSE PASSES 13 JAN 2023 CUSTOMER REPORTS DIRECT TO HEALTH CANADA REGARDING ACCUSCREEN / GETTING FALSE PASSES- NATUS ADVISED OF THIS REPORT 30 JAN 2023, CUSTOMER HAS BEEN ADVISED TO RETURN THE DEVICE FOR EVALUATION-, REQUESTED UNIT BE SENT BACK AND CUSTOMER REPORTS UNIT IS LOCKED DUE TO HEALTH CANADA REPORT. WILL SEND SIP TO RETURN UNIT FOR EVALUATION. CUSTOMER WILL FOLLOW UP ON HIS SIDE TO REQUEST UNIT BE ALLOWED TO SHIP BACK 07 FEB 2023 -AWAITING RESPONSE FROM CUSTOMER 28 FEB 2023 -DEVICE HAS BEEN RECEIVED IN MIDDLETON AND IS BEING SHIPPED TO TAASTRUP FOR INVESTIGATION 28 MAR 2023 -PROBE HAS BEEN RECEIVED BY TECHNICAL INVESTIGATIONS GROUP AND WILL BE FORWARDED TO PATH FOR INVESTIGATION, SN:(B)(6) PROBE TYPE:8-69-41100 03 APR 2023 - FOLLOW UP WITH THE CUSTOMER TO GET MORE INFORMATION 17 APR 2023 - DATA RECEIVED FROM THE CUSTOMER 05 MAY 2023 -ADDITIONAL INFORMATION FROM THE CUSTOMER "THE TWO PROTOCOLS WERE THE DP21 AND DP12 FOR DPOAES. THE REPLACEMENT UNIT AND NEW PROBE ARE WORKING NORMALLY. THE ISSUE SEEMED TO FOLLOW WITH THE PROBE FROM THE TESTING THAT WAS DONE BY THE END USERS." 01 JUN 2023 -FOLLOW UP QUESTIONS FROM TIG SENT TO CUSTOMER 06 JUN 2023 - RESPONSES RECEIVED FROM CUSTOMER 13 NOV 2023 - REPORT RECEIVED FROM TIG. THE PROBE IS INVESTIGATED BY PATH MEDICAL AND THEY REPORTED THE CAUSE OF THE FALSE PASS, LITTLE INFORMATION REGARDING HOW THE PROBE WAS TESTED THIS AND HOW THEY HAVE FOUND THE ISSUE TO BE WITH THE SEAL, SINCE THEY HAVE THEIR OWN MEASUREMENT METHODS THAT WE HAVE NOT INSIGHTS ON. 21 NOV 2023 - CLOSING THE CASE. SENT DEVICE TO PATH MEDICAL FOR FURTHER INVESTIGATION SINCE WE DO NOT HAVE THE NECESSARY TEST SETUP FOR THE PROBE. THE PROBE WAS SHIPPED TO THEM, AND THEY INVESTIGATED THE PROBE AND REPORTED THE FOLLOWING: · WE EXCHANGED THE PROBE SEAL WHICH GENERATED RESONANCES. · THE SURFACE CHANGES COULD BE GENERATED THROUGH NON SPECIFIED DISINFECTION LIQUID (ONLY 70% ISOPROPYL ALCOHOL ON LOW WET TISSUES). IN ACCUSCREEN MANUAL SECTION 4.3 PAGE 30 THE FOLLOWING RECOMMENDATIONS IS WRITTEN ABOUT STERILE ALCOHOL WIPES. · USE A STERILE ALCOHOL WIPE TO CLEAN THE SURFACES AND WAIT UNTIL THE PROBE BODY, PROBE CABLE AND PROBE PLUG ARE COMPLETELY DRY. · NOTE: A STERILE ALCOHOL WIPE TYPICALLY CONTAINS ISOPROPYL ALCOHOL 70%. IT IS IMPORTANT TO HAVE THE DISINFECTANT IN CONTACT WITH THE SURFACE FOR THE PERIOD SPECIFIED BY THE DISINFECTANT MANUFACTURER TO ENSURE ITS EFFECTIVENESS. CONCLUSION: THE FALSE PASSE ARE GENERATED BY THE SEAL SURFACES THAT HAVE CHANGED AFTER USING UNSPECIFIED DISINFECTION LIQUID. RISK MANAGEMENT FILE REVIEW (PRODUCT AND EVENT) (B)(4) REV 07 - 1077 ACCUSCREEN & ALPHA - RISK ANALYSIS: HAZARD ID 5.45 CAUSE - INCORRECT PASS REFER RESULT ~ ACCEPTED FAILURE RATE DEFINED BY THE ALGORITHMS. INCORRECT MEASUREMENTS LEADING TO ADDITIONAL PATIENT EXAMINATION. HARM - DELAY IN USE OF THE SYSTEM OR TREATMENT. SEVERITY- NEGLIGIBLE (0). RISK LEVEL- MINOR (0).

    Additional Manufacturer Narrative · 0

    ACCUSCREEN / GETTING FALSE PASSES. E-MAIL RECEIVED THE 13 JAN 2023 FROM HEALTH CANADA REQUESTING ADDITIONAL INFORMATION RELATING TO CASE (B)(4). THE REPORTER CLAIMS THAT THE DEVICE WAS RETURNED TO NATUS IN AUGUST 2022, AND THAT THE REPLACEMENT DEVICE THAT THEY RECEIVED ON NOVEMBER 30TH, 2022 HAD THE SAME SERIAL NUMBER AS THE ORIGINAL DEVICE, AND AGAIN PROVIDED FALSE POSITIVE RESULTS WHEN USED IN THE UNIVERSAL NEWBORN HEARING SCREENING PROGRAM IN THE PROVINCE OF MANITOBA DEVICE HAS BEEN REQUESTED FOR RETURN AND EVALUATION.

    Description of Event or Problem · 0

    NATUS MEDICAL ACCUSCREEN ABR/DP TYPE 1077: FALSE SCREENING RESULTS. REPORTED INCIDENT IN WHICH FALSE NEGATIVE SCREENING RESULTS WERE RECEIVED FROM TESTING AN INFANT WHO, UPON FURTHER INVESTIGATION, WAS IN FACT FOUND TO HAVE A HEARING IMPEDIMENT.

    Description of Event or Problem · 0

    NATUS MEDICAL ACCUSCREEN ABR/DP TYPE 1077 - FALSE SCREENING RESULTS REPORTED INCIDENT IN WHICH FALSE NEGATIVE SCREENING RESULTS WERE RECEIVED FROM TESTING AN INFANT WHO, UPON FURTHER INVESTIGATION, WAS IN FACT FOUND TO HAVE A HEARING IMPEDIMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733833 1077 MADSEN ACCUSCREEN, ABR/DP 1077 MADSEN ACCUSCREEN, ABR/DP GWJ NATUS MEDICAL DENMARK APS 8-04-13905

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown