BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEDS BY GEORGE

    MDR report key: 3770335 · Received January 2, 2013

    Report

    Report Number
    3008830652-2013-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 10, 2013
    Report Date
    December 10, 2013
    Manufacturer
    BEDS BY GEORGE, INC
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PARENTS INITIALLY FOLLOWED UP WITH DEALER IN (B)(4) WHO DID NOT RESPOND TO SERVICE BED. FATHER OF PT CALLED MFR ON (B)(4) 2013 TO REPORT ISSUE AND AFTER AN INVESTIGATION AS TO THE CAUSE AND POSSIBLE SOLUTION TO THE PROBLEM, MFR IMMEDIATELY SENT OUT AREA REP TO CHANGE OUT LOCK SYSTEM TO DIFFERENT LOCK SYS IT FELT WOULD NOT HAVE SAME ISSUES. THE FIRST SET OF LOCKS/LATCHES ON THE DOOR FAILED INITIALLY IN (B)(6) 2012 DUE TO EXCESS WEAR FROM CONTINUOUS AND LENGTHY KICKING FROM THE INSIDE OF THE BED BY THE PT. AT THAT TIME, AGAINST THE ADVISE OF THE MFR, THE DEALER CHOSE TO SIMPLY REPLACE LOCKS WITH SAME LOCK SYSTEM RATHER THAT UPDATE TO DIFFERENT LOCKING SYSTEM AT MFR'S RECOMMENDATION AND PT CONTINUED TO USE BED. INITIAL INVESTIGATION BY MFR CONCLUDED THAT BED WAS NOT BEING USED FOR PURPOSE INTENDED AND THUS THE USE EXCEEDED THE DESIGN PARAMETERS. IN SPECIFIC, PT WAS PLACED IN BED DURING NON-SLEEP TIMES, AND LEFT UNATTENDED AND ALLOWED TO KICK REPEATEDLY AT DOOR FOR SEVERAL HOURS ON END. MFR HAS CONTACTED THE PARENTS OF THE PT ON THREE SEPARATE OCCASIONS (ONCE BY PHONE AND TWICE BY E-MAIL) TO DETERMINE EXACT DATE OF INCIDENT WITH NO RESPONSE OR REPLY. THE ONLY INFO GIVEN WAS THAT IT HAPPENED ":SEVERAL" WEEKS PRIOR TO (B)(6) 2013.

    Description of Event or Problem · 1

    PRODUCT USE IS INTENDED TO PROVIDE FALL PROTECTION WHILE SLEEPING AND GUARD AGAINST ENTRAPMENT AND ENTANGLEMENT OR OTHER INJURY THAT WOULD RESULT FROM USING A REGULAR BED THAT IS NOT DESIGNED FOR A DISABLED PERSON. ON (B)(6) 2013, MFR WAS CONTACTED AND INFORMED BY FATHER OF PT WHILE PT WAS IN BED AND TRAPPING HER BETWEEN THE DOOR PANELS. AFTER A THOROUGH INVESTIGATION AND QUESTIONING, IT WAS CONCLUDED THAT DUE TO LONG TERM AND PERSISTENT KICKING OF THE INSIDE OF THE DOOR BY THE PT WHILE LEFT UNATTENDED, THE LATCHES FOR THE LOCKS BECOME WORN CAUSING THEM TO FAIL BY SLIPPING FROM THEIR LOCKING GROOVE LEAVING THE DOOR UNSECURED. THE PARENTS OF PT DID NOT CONTACT THE MFR ONCE THIS WAS KNOWN AND CONTINUED TO USE THE BED IN DISREGARD OF THE MFR'S WRITTEN INSTRUCTIONS AND WARNINGS. ULTIMATELY, ON THIS OCCASION, THE PT AGAIN KICKED THE DOOR FOR A LENGTHY PERIOD OF TIME AND THE LOCKS ONCE AGAIN SLIPPED FROM THEIR GROOVES AND THE DOOR BECOME UNLOCKED. THE PT WAS THEN ABLE TO PUSH HER LEG AND BACK AGAINST THE DOOR AND DUE TO IT'S BIO-FOLD DESIGN AND MIDDLE HINGE COMBINED WITH THE WEIGHT OF THE PT PUSHING OUT AND DOWN ON THE DOOR, THE DOOR WAS ABLE TO OPEN AND LOWER WITH THE PT PINNED BETWEEN THE PANELS OF THE BI-FOLD AND DOOR. THERE WAS NO SERIOUS INJURY, BUT THERE WAS MILD INJURY (BRUISING), SO PARENTS TOOK HER TO THE ER TO BE SAFE. AT THE ER, THEY DID ROUTINE EXAM AND FOUND ONLY DEEP BRUISING, TREATED FOR THE BRUISING AND SENT HER HOME. THE BRUISING LASTED FOR "SEVERAL DAYS." UPON HEARING OF INCIDENT SEVERAL WEEKS LATER, MFR TOLD FAMILY TO STOP USING BED IMMEDIATELY UNTIL ISSUE WAS FIXED OR RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203 BEDS BY GEORGE SS 170 - HI-SIDE SAFETY BED FNL BEDS BY GEORGE, INC SS 170 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR