BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE BLANKET

    MDR report key: 6096857 · Received November 11, 2016

    Report

    Report Number
    3018859-2016-00025
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Report Date
    October 12, 2016
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K103589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGED "SHARP EDGE" CONDITION IS CAUSED WHEN THERE IS A 90 DEGREE CUT ON THE NEOBLUE BLANKET PAD VERSUS THE REQUIRED RADIUS OR CHAMFERED CORNER. ADDITIONAL INVESTIGATION INTO THE CAUSE OF THE 90 DEGREE CUT WILL BE PERFORMED AND DOCUMENTED IN SUPPLIER CORRECTIVE ACTION ORIGINATED ON (B)(6) 2016 UNDER CAPA(B)(4). PRELIMINARY INVESTIGATION CONFIRMED THAT THERE WAS A MALFUNCTION AND THERE MAY BE POTENTIAL FOR INJURY WITH REOCCURRENCE. A 100% INVENTORY INSPECTION WAS COMPLETE AS A RESULT OF THIS EVENT, AND IT WAS CONFIRMED THAT THIS ISSUE IS NOT ISOLATED TO A SINGLE LOT. INVESTIGATION IS ONGOING. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE AS A RESULT OF SUPPLIER INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NATUS COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, A REPRESENTATIVE FROM (B)(6) HOSPITAL CALLED NATUS TECHNICAL SERVICE ALLEGING THAT "A BABY'S LEG WAS CUT ON THE PAD'S EDGE OF THEIR LARGE NEOBLUE BLANKET." AFTER FURTHER COMMUNICATION WITH THE CUSTOMER, TECHNICAL SERVICE CONFIRMED THAT NO PATIENT WAS HARMED AND THAT THE STATEMENT OF "A BABY'S LEG BEING CUT ON THE PAD'S EDGE" WAS INCORRECTLY INTERPRETED BY THE HOSPITAL'S REPRESENTATIVE. THE STATEMENT CAME FROM A NURSE ON DUTY WHEN SHE NOTICED A 90 DEGREE CORNER ON THE BLANKET'S PAD. THE NURSE STATED THAT THERE WAS A POTENTIAL FOR INJURY DUE TO THE SHARP EDGE. TECHNICAL SERVICE CONFIRMED NO PATIENT WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748131 NEOBLUE BLANKET NBBLANKET LBI NATUS MEDICAL INCORPORATED 006245 N042716-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other