BEUDAMED
    FDA Adverse Event Other Summary report: N

    SANDMAN DIGITAL 20 (SD20)

    MDR report key: 1051497 · Received May 16, 2008

    Report

    Report Number
    9680138-2008-00001_2
    Event Type
    Other
    Date Received
    May 16, 2008
    Date of Event
    April 16, 2008
    Report Date
    May 16, 2008
    Manufacturer
    EB NEURO SPA
    Product Code
    GWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A REPORT FROM A SLEEP FACILITY THAT "A PT COMPLAINED OF SHOCKING FEELING THAT OCCURRED WHEN THE CUSTOMER CONNECTED THE PT HEADBOX TO THE HEADBOX CABLE. LATER, THAT EVENING THE PT COMPLAINED OF A TINGLING FEELING FROM THE ISO GROUND LEAD", BUT CONTINUED WITH THE STUDY THROUGHOUT THE NIGHT. IN THE MORNING, THE SLEEP FACILITY FURTHER REPORTED THAT THE PT COMPLAINED OF A BURN WHERE ONE OF THE LEADS HAD BEEN CONNECTED. THE PT WAS REFERRED TO AND TREATED BY A DERMATOLOGIST WHO PRESCRIBED ANTIBIOTIC CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SANDMAN DIGITAL 20 (SD20) * GWL EB NEURO SPA SD20 AMPL/HEADBOX *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other