BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLOBLUE

    MDR report key: 7514835 · Received May 15, 2018

    Report

    Report Number
    9681134-2018-04171
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    February 13, 2018
    Report Date
    April 17, 2018
    Manufacturer
    LAP LASER GMBH
    Product Code
    IWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    A SERVICE ENGINEER IN THE (B)(6) CANCER TREATMENT CENTRE, (B)(6), WENT TO UNPLUG THE POWER SUPPLY UNIT (PSU) OF THE MEDICAL DEVICE APOLLOBLUE AND THE ENTIRE CASING OF THE PSU CAME AWAY IN HIS HAND, EXPOSING POTENTIALLY LIVE PARTS INSIDE. THIS REPRESENTS A HEALTH AND SAFETY HAZARD WHICH MIGHT RESULT IN ELECTRICAL SHOCK. THE PSU IS OF TYPE FW7660M/24 OF THE COMPANY FRIWO GERATEBAU (B)(4). USED BATCH IS 47130. THERE HAS BEEN NO HARM OR SERIOUS DETERIORATION OF PERSONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359795 APOLLOBLUE LASER FOR PATIENT ALIGNMENT IWE LAP LASER GMBH 0007567-0015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention