BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE

    MDR report key: 2864312 · Received November 28, 2012

    Report

    Report Number
    2864312
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 28, 2012
    Manufacturer
    TOLLOS (FORMERLY T.H.E. MEDICAL)
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    ONE THOUSAND POUND CAPACITY OVERHEAD LIFT WAS EMPLOYED TO REPOSITION A PATIENT OF APPROX 725 POUNDS IN WEIGHT. THE OVERHEAD LIFT FAILED TO FUNCTION APPROPRIATELY RESULTING IN 7-8 STAFF MEMBERS HAVING TO MANUALLY REPOSITION THE PATIENT. TOLLOS, INC. NOTIFIED, ASSESSED LIFT SYSTEM AND DETERMINED IT WAS A MANUFACTURER PROBLEM. PER THE CLINICAL MANAGER, THE LIFT HAS NOT BEEN PHYSICALLY REMOVED BUT HAS BEEN PLACED OUT OF ORDER. THE SERVICE MANAGER HAS ORDERED 2 NEW UNITS (U34 & U35) AND WILL REPLACE IT WHEN IT IS AVAILABLE FROM THE MANUFACTURE. THE PATIENT AND NO STAFF MEMBERS WERE HARMED IN THIS EVENT.THE LIFT IS A T.H.E PINNACLE 1000 LBS CAPACITY CEILING MOUNTED LIFT. THE LIFT WAS INSTALLED APPROXIMATELY TWO MONTHS AGO BY THE MANUFACTURER'S SUBCONTRACTOR. THE PATIENT WAS ON THE LIFT WHEN STAFF NOTICED IT DID NOT LIFT THE PATIENT HIGH ENOUGH FROM THE BED TO PERFORM NURSING CARE. THESE LIFTS ARE NEW AND HAVE NOT HAD ANY PROBLEMS. WE HAVE NO IDEA WHY THIS HAPPENED. THE SERVICE MANAGER DETERMINED THE MALFUNCTION TO BE DUE TO THE LIFT STRAP NOT GOING ALL THE WAY TO THE TOP. SPECIFICALLY, THEY MADE NOTE OF PART #3000-378 CEILING LIFT CONTROL MODULE GEN 3, ON THE SERVICE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE LIFT, PATIENT FNG TOLLOS (FORMERLY T.H.E. MEDICAL) PINNACLE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *