BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMA BAR ACTIVATED 2-SECTION BOBATH TABLE

    MDR report key: 5044606 · Received September 1, 2015

    Report

    Report Number
    5044606
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 28, 2015
    Manufacturer
    PATTERSON MEDICAL COMPANIES INC
    Product Code
    INQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN OCCUPATIONAL THERAPY PATIENT WAS SITTING ON A CHAIR NEXT TO THE HI-LO TABLE. HE PLACED HIS FOOT ON THE LEVER THAT LOWERS THE TREATMENT TABLE. THE TABLE BEGAN LOWERING. THE OCCUPATIONAL THERAPISTS SAW THE TABLE LOWERING TOWARDS THE PATIENT'S LEG AND TOLD THE PATIENT TO TAKE HIS FOOT OFF OF THE LEVER. THE PATIENT DID NOT RESPOND (HE IS S/P CVA AND THIS MAY HAVE CONTRIBUTED TOWARDS HIS NOT RESPONDING OR NOTICING THE TABLE WAS LOWERING). THE TABLE LOWERED ONTO THE PATIENT'S KNEE AND CONTINUED TO LOWER (AS THE PATIENT'S FOOT WAS STILL DEPRESSING THE BAR). HIS LEG BECAME ENTRAPPED AND THERE WAS AN AUDIBLE CRACKING SOUND. THE OCCUPATIONAL THERAPIST SPRAINED HER WRISTS FREEING THE PATIENT'S LEG. THE DEVICE DOES NOT DETECT AN OBSTRUCTION IN THE MOVEMENT PATH WHEN IT IS ENGAGED. SO LONG AS THE LEVER IS DEPRESSED, THE DEVICE WILL COMPLETE ITS MOVEMENT PATH TO THE MANUFACTURER'S PRESET ENDPOINT REGARDLESS OF OBSTRUCTION. THE PATIENT WAS ULTIMATELY BROUGHT VIA AMBULANCE TO ANOTHER HOSPITAL. REPORTEDLY, HE WAS FOUND TO HAVE A FRACTURED ANKLE. DURING OUR INVESTIGATION, WE HAVE NOTED THAT WE RECENTLY PURCHASED A SECOND TABLE FROM THE SAME MANUFACTURER. THE TABLE INVOLVED IN THIS MATTER LOWERS WHEN THE LEVER IS DEPRESSED AND RISES WHEN THE LEVER IS LIFTED. THE OTHER TABLE OPERATES IN THE OPPOSITE FASHION (LOWERS WHEN THE LEVER IS RAISED AND RISES WHEN THE LEVER IS DEPRESSED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577963 PERFORMA BAR ACTIVATED 2-SECTION BOBATH TABLE TABLE, POWERED INQ PATTERSON MEDICAL COMPANIES INC 081502236

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other