BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEP SOLUTION TESTER

    MDR report key: 2666972 · Received July 23, 2012

    Report

    Report Number
    MW5026257
    Event Type
    Malfunction
    Date Received
    July 23, 2012
    Date of Event
    July 1, 2010
    Report Date
    July 23, 2012
    Manufacturer
    NOVASOM, INC
    Product Code
    MNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TWO YEARS AGO, THE (B)(6) GAVE RPTR A SLEEP APNEA TESTING MACHINE TO TEST WHETHER HE HAD SLEEP APNEA. THE MACHINE MALFUNCTIONED BY GIVING HIM THE WRONG DIAGNOSIS OF HIM HAVING SLEEP APNEA, WHEN HE DID NOT. PT WAS ALMOST PUT ON SLEEP APNEA MEDICATION BY THE (B)(6). PT BELIEVES THAT THERE ARE MORE (B)(6) PTS THAT HAVE BEEN GIVEN THE WRONG DIAGNOSIS BY THE MACHINE. THE DEVICE IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEP SOLUTION TESTER MNR NOVASOM, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other