BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTIC STIM

    MDR report key: 8110329 · Received November 28, 2018

    Report

    Report Number
    9612330-2018-00022
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    August 27, 2015
    Report Date
    August 27, 2015
    Manufacturer
    NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK)
    Product Code
    GWE
    PMA / PMN Number
    K991903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING NATUS COMPLAINT PROCEDURE, THE PHOTIC SYSTEM WAS INVESTIGATED. THE CABLE FOUND BROKEN AT THE END OF LOWER ARM. NORMAL WEAR AND TEAR FAILURE DUE TO THE MECHANICAL MOVEMENT. REPLACEMENT DEVICE PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    SPARK WAS OBSERVED ON PHOTIC DEVICE. POWER CORD WAS FOUND DAMAGED UPON INSPECTION OF THE DEVICE, INCIDENT HAS NO EFFECT ON PATIENT/USER SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952639 PHOTIC STIM PHOTIC STIMULATOR GWE NATUS MEDICAL INC. DBA EXCLE-TECH LTD (XLTEK)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other