BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRA

    MDR report key: 453916 · Received April 8, 2003

    Report

    Report Number
    MW1028123
    Event Type
    Malfunction
    Date Received
    April 8, 2003
    Date of Event
    March 19, 2003
    Report Date
    April 9, 2003
    Manufacturer
    HILL-ROM
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIRE WITH HILL-ROM 850 ELECTRIC BED. BED FIRE EXPERIENCED ON HILL-ROM MODEL 850 ELECTRIC BED IN 2003. PT'S PARENT HEARD LOUD NOISE FROM BED AND OBSERVED SMOKE AND FLAMES FROM UNDER BED. PT MOVED TO SAFETY WITHOUT HARM, FIRE EXTINGUISHED AND BED REMOVED FROM PT AREA. INSPECTION REVEALED THAT MOTOR CAPACITOR HAD BLOWN AND EITHER IGNITED CAPACITOR CONTENTS OR SHORTED OTHER COMPONENTS. HILL-ROM THEN INFORMED RPTR THAT THEY HAD NOTIFIED CUSTOMERS IN A LETTER DATED JULY 15, 1991 THAT THIS TYPE OF FAILURE WAS POSSIBLE AND THAT THEY "ENCOURAGED" CUSTOMERS TO REPLACE ALL CAPACITORS WITH A NEWER STYLE. RPTR HAS NO RECORD OF RECEIPT OF THAT LETTER AND THERE WAS NEVER ANY ALERT FROM ECRI, FDA, OR OTHER WATCHDOG AGENCIES. REVIEW OF MAUDE DATABASE SHOWED ONE SIMILAR INCIDENT. RPTR HAD OVER 60 BEDS OF THIS MODEL AND FOUND SEVERAL WITH OLD STYLE CAPACITORS. THE MANUFACTURER'S SERVICE REP WAS ALSO NOT AWARE THAT THE CAPACITORS SHOULD HAVE BEEN UPGRADED. SEVERAL OTHER BED MODEL NUMBERS FROM HILL-ROM ARE ALSO AFFECTED (450, 550, 715, 720, 815, 820, 835, 840, 850, 894, 1120, 1130, 1140).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRA ELECTRIC BED FNL HILL-ROM 850 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *