BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITRON RITEHITE

    MDR report key: 3841213 · Received February 27, 2014

    Report

    Report Number
    1824206-2014-00647
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    PMA / PMN Number
    K964223
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH FOUND THE NURSE WAS ONLY SETTING THE BRAKE AT THE HEAD OF THE BED, INSTEAD OF SETTING BOTH THE HEAD AND FOOT END BRAKES. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECH TESTED THE BRAKES AND FOUND NO ISSUES. THEY WERE FUNCTIONING AS DESIGNED. THE TECH INSERVICED THE STAFF ON THE PROPER SETTING OF BOTH THE HEAD AND FOOT END BRAKES TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BRAKES WERE NOT HOLDING. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYS AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121821 CLINITRON RITEHITE BED, AIR FLUIDIZED INX HILL-ROM, INC. 0800

    Patients

    Seq Age Sex Outcome Treatment
    1