BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1031452-2015-15732

    MDR report key: 5039295 · Received August 28, 2015

    Report

    Report Number
    1031452-2015-15732
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Report Date
    August 13, 2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO END USER INFORMATION PROVIDED. THE PRODUCT WAS EVALUATED AND REPAIRED BY AN INDEPENDENT REPAIR CENTER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    PER THE INDEPENDENT REPAIR CENTER, THE CUSTOMER ALLEGED PROBLEM IS THE UNIT ALARMS ARE NOT FUNCTIONAL. THE KEY FAILURE IS THE ON OFF SWITCH HAS A SHORT CIRCUIT.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other