BEUDAMED
    FDA Adverse Event Other Summary report: N

    BED PKG HI/LOW 29"RLS H/F-QUAR

    MDR report key: 1593719 · Received January 13, 2010

    Report

    Report Number
    1417592-2010-00001
    Event Type
    Other
    Date Received
    January 13, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 11, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A MAINTENANCE MAN WAS ATTEMPTING TO REPLACE THE ACTUATOR ON A BED AND WAS SEVERELY INJURED WHEN IT BROKE. THE MAINTENANCE MAN WAS APPARENTLY UNDER THE BED WHEN HE REMOVED THE ACTUATOR AND THE BED DROPPED ON HIS SHOULDER. A PHOTO SHOWS A SPLIT ON THE LEG SUPPORT OF THE BED WITH SCRATCHES/PILLING OF WHITE COATING AROUND THE WELDED PORTION OF THE BRACE FRAME. WE ARE NOT ABLE TO DETERMINE THE CAUSE(S) OF THE FAILURE AS THE SAMPLE WAS NOT RECEIVED FROM THE CUSTOMER AFTER MULTIPLE ATTEMPTS. IT IS UNKNOWN IF THE FRAME BROKE BEFORE OR AFTER THE MAINTENANCE PERSON WAS UNDERNEATH THE BED TO TAKE OFF THE ACTUATOR. PICTURES OF THE ACTUATOR WERE NOT SENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE ACCOUNT HAS NOT RETURNED CALLS AFTER MULTIPLE MESSAGES LEFT. THE EXTENT OF INJURIES IS NOT KNOWN. THERE ARE LIMITED DETAILS OF THE INCIDENT PROVIDED. THE OWNER'S MANUAL SPECIFICALLY STATES THAT "WHEN DISASSEMBLING THE BED, MAKE SURE ALL PARTS ARE IN THE LOWEST POSITION." IT ALSO STATES "NEVER PERMIT ANYONE TO BE UNDER THE BED OR IN BETWEEN THE RAISED BED FRAME COMPONENTS AT ANY TIME." HOWEVER, DUE TO THE STATEMENT THAT THE MAINTENANCE MAN WAS 'SEVERELY' INJURED, THIS MDR IS BEING FILED.

    Description of Event or Problem · 1

    REPORTEDLY, WHILE THE MAINTENANCE MAN WAS WORKING ON THE BED, THE ACTUATOR BROKE AND HE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED PKG HI/LOW 29"RLS H/F-QUAR NONE FNL MEDLINE INDUSTRIES, INC. FCE1232QO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other