BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1077 MADSEN ACCUSCREEN, ABR/TE INCLUDING STANDARD ACCESSORIES INCL. PROBE

    MDR report key: 11313862 · Received February 11, 2021

    Report

    Report Number
    9612197-2021-00001
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    February 7, 2021
    Report Date
    February 8, 2021
    Manufacturer
    NATUS MEDICAL DENMARK
    Product Code
    EWO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 (REF NATUS COMPLAINT# (B)(4). A DEVICE HISTORY REVIEW IS NOT REQUIRED, AS THE DEVICE WAS IN SERVICE FOR MORE THAN TWO YEARS. INSTALLED: 01 JAN 2001. A SEARCH FOR SERVICE DATA THAT MAY BE RELEVANT TO THIS ISSUE HAS BEEN CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE FOUND. THE PRODUCT WAS NOT REQUESTED FOR RETURN. PRODUCT EXAMINATION, FUNCTIONAL TESTING WAS PERFORMED ON-SITE, AND CAUSE WAS DETERMINED. INVESTIGATION RESULT CODE: BATTERY. A REPLACEMENT WAS SUPPLIED - 8-73-02400 1077 BATTERY (LI-LON 3.7 V, 1800) X 1 SHIPPED 10 FEB 2021 (9790213064). DOC-043316 REV A LISTS THE POTENTIAL HAZARD OF DELAY IN TREATMENT OR DIAGNOSIS, OR PATIENT DISCOMFORT DUE TO DEVICE NOT AVAILABLE FOR USE - HARM - DELAY IN TREATMENT OR DIAGNOSIS, OR PATIENT DISCOMFORT. CAUSE- DEVICE NOT AVAILABLE FOR USE - NON-RESPONSIVE DEVICE . SEVERITY- NEGLIGIBLE (0). RISK LEVEL- MINOR (0). THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (QMS-004442 CORPORATE TRENDING AND ANALYSIS PROCEDURE ) AND ANY COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW DOCUMENTED ON DOC-052150- QUARTERLY QA TRENDING. NO TREND FOR THIS DEVICE WAS IDENTIFIED .

    Description of Event or Problem · 0

    WHILE POWERING DEVICE ON, THE USER NOTICED THE BATTERY HAD BECOME SWOLLEN AND REQUIRED REPLACEMENT. NO INJURY. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(6) 2021 INITIAL REPORT REF NATUS COMPLAINT# (B)(4). WHILE POWERING DEVICE ON, THE USER NOTICED THE BATTERY HAD BECOME SWOLLEN AND REQUIRED REPLACEMENT. NO INJURY. NO PATIENT INVOLVEMENT. THIS EVENT HAS THE POTENTIAL TO CAUSE INJURY, IF IT WERE TO RECUR, IF THE BATTERY IS NOT REPLACED.

    Description of Event or Problem · 1

    WHILE POWERING DEVICE ON, THE USER NOTICED THE BATTERY HAD BECOME SWOLLEN AND REQUIRED REPLACEMENT. NO INJURY. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209918 1077 MADSEN ACCUSCREEN, ABR/TE INCLUDING STANDARD ACCESSORIES INCL. PROBE 1077 MADSEN ACCUSCREEN, ABR/TE INCLUDING STANDARD ACCESSORIES INCL. PROBE EWO NATUS MEDICAL DENMARK 8-04-13904

    Patients

    Seq Age Sex Outcome Treatment
    1