BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1076 AURICAL OTOCAM 300

    MDR report key: 12084044 · Received June 29, 2021

    Report

    Report Number
    9612197-2021-00009
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    April 29, 2021
    Report Date
    December 9, 2021
    Manufacturer
    NATUS MEDICAL DENMARK
    Product Code
    ERA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 (REF NATUS COMPLAINT (B)(4)). IT HAS BEEN AGREED NOT TO REQUEST THE DEVICE FROM THE CUSTOMER. IT WAS CONFIRMED THE FOLLOWING WERE SUPPLIED WITH DEVICE: OTOCAM 300, MAGNETIC OTOCAM STAND/HOLDER (ALLEN KEY + SCREW ASSEMBLY), 1X PACK OF SPECULA 3MM NORMAL, 1X PACK OF SPECULA 3MM CERUMEN, SPECULA HOLDER X2, OTOCAM 300 INSTALLATION RECOMMENDATIONS & OTOSUITE PC SOFTWARE DISC. CAPA005081 IS RELATED TO THIS ISSUE. THE CAPA IS RECOMMENDED FOR OTOCAM 300 PRODUCT FAILURE MODES AND INCLUDES THE FAILURE MODE - CONSTANT BLURRED PICTURE ROOT CAUSE WAS DETERMINED TO MOST LIKELY BE: 3 OUT OF THE 10 RETURNED COMPLAINT DEVICES RELATED TO PICTURE QUALITY WERE FOUND TO BE SUBSTANTIATED BY THE TIG TEAM. FOR TWO OUT OF THESE COMPLAINT DEVICES IT WAS OBSERVED THAT THE LENS-1, 1-10-72100 WAS MISSING. IN THE OTHER CASE THE LENS-1 WAS BROKEN DUE TO IMPACT ON THE LENS. IT WAS CONCLUDED THAT THE ABSENCE OF AND DAMAGE TO THE LENS WOULD RESULT IN THE FAILURE MODE OBSERVED. FAILURE CONFIRMED: YES INVESTIGATION RESULT CODE: TAASTRUP/DISPLAY/IMAGE CLOSURE RATIONALE:COMPLAINT VERIFIED, CAPA INIATED OR ALREADY OPEN. THERAPEUTIC GOODS ADMINISTRATION HAVE ADVISED THAT NO FURTHER INVESTIGATION OF THE REPORTED EVENT WILL OCCUR.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT (REF NATUS COMPLAINT (B)(4)) UPDATE TO DESCRIPTION SECTION B.5 CORRECTION TO G.2 SECTION D4., UNIQUE IDENTIFIER (UDI) PROVIDED AS (B)(4). BASIC UDI-DI (B)(4) IS ALSO RELATED TO THIS PART. CAPA005081 IS OPENED AND IS RELATED TO THIS ISSUE (REF TO OTOCAM 300 PRODUCT FAILURE MODES). THIS CAPA IS CURRENTLY AT CAPA PLAN APPROVAL. AWAITING AN UPDATE ON THE STATUS OF THIS AFFECTED PRODUCT. THERAPEUTIC GOODS ADMINISTRATION HAVE ADVISED THAT NO FURTHER INVESTIGATION OF THE REPORTED EVENT WILL OCCUR. TGA WILL CONTINUE TO MONITOR THE RATE AND PATTERN OF OCCURRENCE OF THE REPORTED ADVERSE EVENT AND MAY RE-OPEN THE FILE AS APPROPRIATE.

    Description of Event or Problem · 0

    AN INCIDENT REPORT WAS RECEIVED BY THE THERAPEUTIC GOODS ADMINISTRATION FROM A HEALTHCARE PROFESSIONAL/USER. A AURICAL OTOCAM PURCHASED IN 2018 IS NOW PRODUCING BLURRY IMAGES. THE REPORTER STATES THEY DID NOT RECEIVE ANY OPERATION MANUAL WITH THE PRODUCT WHICH LED TO A MALFUNCTION. THIS ISSUE (THAT WAS WRITTEN INTO THE MANUAL THAT THEY DID NOT RECEIVE) COULD HAVE LED TO A MISDIAGNOSIS ON A CHILD. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    AN INCIDENT REPORT WAS RECEIVED BY THE THERAPEUTIC GOODS ADMINISTRATION FROM A HEALTHCARE PROFESSIONAL/USER. A AURICAL OTOCAM PURCHASED IN 2018 IS NOW PRODUCING BLURRY IMAGES. THE REPORTER STATES THEY DID NOT RECEIVE ANY OPERATION MANUAL WITH THE PRODUCT WHICH LED TO A MALFUNCTION. THIS ISSUE (THAT WAS WRITTEN INTO THE MANUAL THAT THEY DID NOT RECEIVE) COULD HAVE LED TO A MISDIAGNOSIS ON A CHILD. NO INJURIES REPORTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT (REF NATUS COMPLAINT (B)(4)). CUSTOMER REPORTS OTOCAM 300 HAS CLOUDY IMAGES. CUSTOMER STATES THAT THEY DID NOT RECEIVE ANY OPERATION MANUAL WITH THIS PRODUCT WHICH HAS NOW LED TO A MALFUNCTION. CUSTOMER HAS BEEN ADVISED TO RETURN THE DEVICE FOR EVALUATION. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (QMS-004442 CORPORATE TRENDING AND ANALYSIS PROCEDURE) COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW DOC- (B)(4). NO TREND FOR THIS FAILURE IDENTIFIED. THE CURRENT RISK FILE DOC-(B)(4) OTOCAM 300 REV 06 HAZARD ID 5.31 IDENTIFIES THIS ISSUE HARM - IT IS NOT POSSIBLE TO MAKE A DIAGNOSIS - LEADS TO DELAYED PROCEDURE. CAUSE- UNCLEAR IMAGE. SEVERITY- NEGLIGIBLE (0). RISK LEVEL- MINOR (0). A RISK REVIEW IS NOT REQUIRED AS 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTS 1076 AURICAL OTOCAM 300 CLOUDY IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986381 1076 AURICAL OTOCAM 300 1076 AURICAL OTOCAM 300 ERA NATUS MEDICAL DENMARK 8-04-13250

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown