BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID RESPONSE HUT

    MDR report key: 5100210 · Received September 24, 2015

    Report

    Report Number
    5100210
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    July 23, 2015
    Report Date
    September 8, 2015
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PERFORMING A TILT TABLE TEST. PATIENT PASSED OUT AND THE TILT TABLE WOULD NOT GO DOWN TO SUPINE POSITION. RED EMERGENCY BUTTON DID NOT WORK NOR DID THE DOWN BUTTON OF THE TABLE CONTROL PANEL. PATIENT WAS BEGINNING TO SEIZE WHEN MANUALLY PULLING THE TABLE TO SUPINE POSITION. MANUFACTURER RESPONSE FOR TABLE EXAMINATION - TILT, (BRAND NOT PROVIDED) (PER SITE REPORTER): WE WILL NOTIFY THE MANUFACTURER TODAY OR TOMORROW. THIS UNIT HAD ALREADY BEEN UPGRADED BASED ON A PREVIOUS RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630495 RAPID RESPONSE HUT TABLE, EXAMINATION, MEDICAL, POWERED LGX MEDICAL POSITIONING, INC. RRHUT1017

    Patients

    Seq Age Sex Outcome Treatment
    1