BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT HELPER W/LOCKING LEVER

    MDR report key: 5666101 · Received May 29, 2013

    Report

    Report Number
    2921578-2013-00021
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    December 6, 2012
    Report Date
    May 14, 2013
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    KQZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT WHO HAD UNDERGONE TOTAL HIP REPLACEMENT, WHEN RECUPERATING FROM THE SURGERY IN A HILL ROM VERSACARE BED THAT HAD OUR 3423 MIZUHO OSI PATIENT HELPER ATTACHED TO THE BED. TWO NURSES WERE ASSISTING THE PATIENT TO REPOSITION HIMSELF. DURING THE REPOSITIONING, THE TRAPEZE THAT THE PATIENT GRASPED SLIPPED THROUGH THE "S" HOOK OPENING (THE "S" HOOK IS AT THE JUNCTION WHERE THE CHAINS ON THE TRAPEZE THAT ALSO CONNECT TO THE MAIN ADJUSTABLE CHAIN THAT EXTENDS DOWN FROM THE PATIENT HELPER). THE TRAPEZE FELL AND HIT THE PATIENT ON HIS CHEST. AT THAT TIME THERE WAS NO VISIBLE INJURY TO THE PATIENT. THE NURSE COMPLAINED THAT SHE SUFFERED AN INJURY TO HER PREVIOUSLY INJURED CERVICAL SPINE. THIS INCIDENT AGGRAVATED HER PREVIOUS CONDITION CAUSING HER TO HAVE CERVICAL SPINAL SURGERY TO CORRECT THE INJURY. THE PATIENT LATER CONTACTED THE HOSPITAL AND FILED A COMPLAINT ATTRIBUTING A SORE TRAPEZIUS MUSCLE CAUSED BY THE FAILURE OF THE ATTACHED TRAPEZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237951 PATIENT HELPER W/LOCKING LEVER KQZ MIZUHO ORTHOPEDIC SYSTEMS, INC. 3423

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR