BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITE HITE

    MDR report key: 2142683 · Received June 22, 2011

    Report

    Report Number
    2142683
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 22, 2011
    Manufacturer
    HILL-ROM
    Product Code
    INX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IS A PARAPLEGIC AND USING THIS SPECIALTY BED WITH THE RAILS UP. PATIENT USING RAILS TO PULL HIMSELF UP IN BED. WHILE PULLING SELF UP WITH RAILS, ONE OF THE RAILS COLLAPSED CAUSING PATIENT TO FALL OUT OF BED. THE PATIENT WAS PLACED IN THIS BED AND DID HAVE SOME PROBLEMS WITH THE SIDE RAIL COLLAPSING WHEN PULLING HIMSELF UP. THE MANUFACTURERS REPRESENTATIVE WAS NOTIFIED AND CAME OUT TO THE HOSPITAL TO REPAIR THE BED AND SAID IT WAS REPAIRED BEFORE HE LEFT AND THE BED WAS RETURNED TO SERVICE. IT WAS AFTER THE "REPAIR" THAT THE SIDE RAIL COLLAPSED AGAIN AND THE PATIENT FELL. I AM NOT SURE HOW LONG AFTER THE REPAIR THIS HAPPENED. A NEW BED FROM A DIFFERENT COMPANY WAS REQUESTED AND PATIENT WAS PLACED IN THE NEW BED. THE CLINITRON BED IS A RENTAL BED. THE ONLY TREATMENT THAT WAS REQUIRED FOR THE PATIENT WAS THE PROVISION OF A BRACE TO ENSURE STABILITY OF THE FRACTURE. AS THE PATIENT IS PARAPLEGIC, MEDICAL MANAGEMENT WAS ELECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITRON RITE HITE HOSPITAL SPECIALTY BED INX HILL-ROM * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR NO OTHER THERAPIES