BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS BILIBAND EYE PROTECTOR

    MDR report key: 6434974 · Received March 27, 2017

    Report

    Report Number
    3018859-2017-00228
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Report Date
    February 24, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    FOK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS A "CAUTION" IN THE BILIBAND INSTRUCTIONS FOR USE THAT INSTRUCT THE USER TO "AVOID OBSTRUCTING THE NOSE AND CHECK REGULARLY THAT THIS DOES NOT OCCUR." THE INSTRUCTIONS ALSO INCLUDE A DIAGRAM AND INSTRUCTIONS EXPLAINING PROPER POSITIONING AND FASTENING OF THE BILIBAND. THE CUSTOMER PROVIDED NATUS A PICTURE, WHICH DISPLAYS IMPROPER USE OF THE BILIBAND DEVICE. INVESTIGATION OF THESE EVENTS HAS CONCLUDED THAT EITHER IMPROPERLY SECURED BILIBANDS OR IMPROPER SIZING OF THE BILIBAND CAUSING A LOOSE FIT OR OVERSTRETCHED PRODUCT ARE THE CAUSES OF THE REPORTED EVENTS. REVIEW OF COMPLAINT RECORDS DETERMINED THERE HAS BEEN NO CUSTOMER REPORT ON THE BILIBANDS GETTING INTO INFANT'S MOUTHS IN THE PAST FIVE YEARS. THE END USER HAS BEEN PROVIDED INSTRUCTIONAL DOCUMENTATION AND TRAINING ON THE USE OF THE BILIBAND DEVICE AFTER THESE REPORTED EVENTS. PLEASE NOTE THAT ADDITIONAL INFORMATION, SUCH AS PATIENT INFORMATION OR DATE OF EVENT, WERE REQUESTED FROM THE CUSTOMER. THIS REPORT IS CONSIDERED FINAL AND THIS INVESTIGATION IS CONCLUDED. CUSTOMER COMMUNICATION.

    Additional Manufacturer Narrative · 1

    THERE IS A "CAUTION" IN THE BILIBAND INSTRUCTIONS FOR USE THAT INSTRUCT THE USER TO "AVOID OBSTRUCTING THE NOSE AND CHECK REGULARLY THAT THIS DOES NOT OCCUR." THE INSTRUCTIONS ALSO INCLUDE A DIAGRAM AND INSTRUCTIONS EXPLAINING PROPER POSITIONING AND FASTENING OF THE BILIBAND. REVIEW OF COMPLAINT RECORD DETERMINED THERE HAS BEEN NO CUSTOMER REPORT ON THE BILIBANDS GETTING INTO INFANT'S MOUTHS IN THE PAST FIVE YEARS. THIS INVESTIGATION IS ONGOING AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. SAMPLES FROM USER FACILITY REQUESTED.

    Description of Event or Problem · 1

    NATUS RECEIVED A CUSTOMER COMPLAINT INDICATING THAT "THREE INCIDENTS WHERE INFANTS WERE ABLE TO GET THE BILIBANDS INTO THEIR MOUTHS, ALMOST CHOKING." INVESTIGATION OF THE EVENTS CONCLUDED THAT IMPROPERLY SECURED BILIBANDS OR IMPROPER SIZING OF THE BILIBAND CAUSING A LOOSE FIT OR OVERSTRETCHED PRODUCT ARE THE LIKELY CAUSES OF THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218562 NATUS BILIBAND EYE PROTECTOR BILIBAND FOK NATUS MEDICAL INCORPORATED 900642, 900643

    Patients

    Seq Age Sex Outcome Treatment
    1 Other