BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALGO 5 NEWBORN HEARING SCREENER

    MDR report key: 8857955 · Received August 2, 2019

    Report

    Report Number
    3018859-2019-00007
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    May 26, 2019
    Report Date
    July 10, 2019
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWJ
    PMA / PMN Number
    K073665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED UNIT WAS RETURNED BACK TO NATUS FOR EVALUATION ON 8/30/2019, NATUS FACTORY SERVICE DID THE EVALUATION ON 9/3/2019 AND NOTED "COMPLAINT THAT UNIT GIVES A FALSE PASS, COULD NOT BE CONFIRMED. USED DOC-(B)(4) AND A KNOWN GOOD WORKING SYSTEM TO TEST MONITOR. MONITOR PASSED ALL TEST AND WILL BE CONVERTED TO REFURBISH, AND BE PUT BACK INTO STOCK. ADDITIONAL INFO: THE ENTIRE ALGO5 SYSTEM WAS INITIALLY TESTED AS A SET BY PERFORMING A PASS AND REFER TEST USING THE 040586 ALGO AABR SIMULATOR (PROP#11371, DUE:11/8/19).WITH THE SIMULATOR TURNED ON, SCREENING TEST WAS EXECUTED AND PASSED. SIMULATOR WAS THEN TURNED OFF. SCREENING TEST WAS EXECUTED TO FORCE THE SYSTEM TO REFER AND IT DID." NATUS WAS UNABLE TO CONFIRM COMPLAINT OF "FLASE PASS", UNIT WAS TESTED PER ALGO 5 TEST RECORD AND FOUND NO ISSUES.

    Additional Manufacturer Narrative · 1

    THE FALSE PASS SCREENING RESULT BY THE ALGO DEVICE DESCRIBED IN THIS COMPLAINT IS A MALFUNCTION. ALTHOUGH THERE WAS NO REPORT OF PATIENT/USER DEATH OR SERIOUS INJURY (A DELAY IN DIAGNOSIS DID NOT OCCUR), THIS COMPLAINT WILL BE REPORTED TO THE FDA BECAUSE THE RISK ASSOCIATED WITH THE HAZARD OF FALSE PASS HAS BEEN DETERMINED TO BE A MODERATE RISK. THE SUSPECTED UNIT WAS REQUESTED BACK TO NATUS FOR EVALUATION AND A REPLACEMENT ALGO 5 SYSTEM WAS SENT TO CUSTOMER TO PREVENT DELAY IN SCREENING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE NATUS WILL SUBMIT A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NATUS THAT ALGO 5 HEARING SCREENER RESULTS WERE QUESTIONABLE TO THE USER. CUSTOMER STATED THAT THE PATIENT HAS ARTESIA ON THE LEFT EAR AND THE SCREENER PERFORMED A SCREENING WHICH RESULTED IN PASSING RESULTS ON THIS EAR. NATUS TECHNICAL SERVICE REPRESENTATIVE SUGGESTED CUSTOMER TO DISCONTINUE USE OF THE DEVICE AND REQUESTED ANSWERS TO ADDITIONAL QUESTIONS REGARDING THE EVENT. AFTER THE INITIAL FOLLOW UP WITH CUSTOMER BY NATUS TECHNICAL SERVICE REPRESENTATIVE, IT WAS CONFIRMED THAT THE SCREENING WAS PERFORMED WHILE THE PATIENT WAS SLEEPING AND THERE WERE NO SENSOR ADHESION ISSUES. THE DOCTOR REFERRED THE PATIENT TO AN OUTSIDE AUDIOLOGIST. THE COMPLAINANT DID NOT HAVE ANY MORE FOLLOW UP INFORMATION. THE ENTIRE ALGO5 SYSTEM WAS REQUESTED FOR RETURN TO NATUS FOR EVALUATION AND TESTING. A REPLACEMENT ALGO 5 SYSTEM WAS PROVIDED TO CUSTOMER TO PREVENT DELAY IN SCREENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650001 ALGO 5 NEWBORN HEARING SCREENER ALGO 5 GWJ NATUS MEDICAL INCORPORATED 000619

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other