BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE-DRIER 44

    MDR report key: 5760624 · Received June 29, 2016

    Report

    Report Number
    3018859-2016-00002
    Event Type
    Malfunction
    Date Received
    June 29, 2016
    Report Date
    June 29, 2016
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LDS
    PMA / PMN Number
    K953645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS MEDICAL INCORPORATED IS CONTINUING TO INVESTIGATE THIS EVENT IN ORDER TO DETERMINE THE ROOT CAUSE OF THE FAILURE. NATUS IS ATTEMPTING TO RETURN DEVICE FOR EVALUATION, AT THIS TIME IT IS UNKNOWN IF DEVICE WILL RETURN AS REQUESTED BY NATUS. A FOLLOW UP REPORT WILL BE SUBMITTED IF FAILED DEVICE IS RETURNED FOR EVALUATION OR ANY ADDITIONAL INFORMATION OBTAINED TO COMPLETE INVESTIGATION. UNKNOWN IF DEVICE WILL BE RETURNED.

    Description of Event or Problem · 1

    CUSTOMER CALLED AND STATED THAT STERILE DRIER 44 DEVICE FAILED AND CAUSED A SPARK WHICH CAUSED CONSIDERABLE BURNS INSIDE THE DRYER. PHOTOS PROVIDED BY THE CUSTOMER SHOW EVIDENCE OF ABNORMAL HEAT IN UPPER COMPARTMENT WHICH MELTED STYROFOAM; HOWEVER PHOTOS REVEALED NO INDICATION OF FIRE OR BURNS IN THE VICINITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413461 STERILE-DRIER 44 STERILE-DRIER 44 LDS NATUS MEDICAL INCORPORATED 54344-M320

    Patients

    Seq Age Sex Outcome Treatment
    1