BEUDAMED
    FDA Adverse Event Other Summary report: N

    MODEL 720 BED

    MDR report key: 3608254 · Received January 23, 2014

    Report

    Report Number
    1824206-2014-00216
    Event Type
    Other
    Date Received
    January 23, 2014
    Date of Event
    December 9, 2013
    Report Date
    December 30, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESIDENT WAS STATUS POST OPEN REDUCTION, INTERNAL FIXATION OF THE LEFT HIP. SHE WAS ADMITTED TO THE REHABILITATION UNIT OF USER FACILITY ON (B)(6) 2013. SHE HAD A HISTORY OF MILE DEMENTIA. THE UPPER SIDE RAILS ON THE RESIDENT'S BED WERE UTILIZED TO ASSIST IN BED MOBILITY. MATTRESS FROM JOERNS HEALTHCARE AND MATTRESS OVERLAY FROM EHOB, INCORPORATED WAS ON THE BED FROM (B)(6) 2013. THE HILL-ROM TECHNICIAN INVESTIGATED THE ALLEGED INCIDENT AND WAS DENIED ACCESS TO THE BED, WHICH WAS BEING HELD IN STORAGE. THE TECHNICIAN SPOKE WITH THE ACCOUNT AND THEY WOULD NOT RELEASE ANY FURTHER INFORMATION REGARDING THE ALLEGED INCIDENT. PRELIMINARY VERBAL AUTOPSY REPORT CONCLUSION WAS RESIDENT DIED DUE TO ASPHYXIATION, SECONDARY TO ACCIDENTAL STRANGULATION. CHRONIC CORONARY ARTERY DISEASE WAS FOUND ON AUTOPSY BUT NOT BELIEVED TO BE PRIMARY CAUSE OF DEATH. THE TOXICOLOGY RESULTS AS TO PRESENCE OF OXYCODONE IN RESIDENT'S SYSTEM ARE PENDING. HILL-ROM WAS DENIED ACCESS TO THE BED FOR PROPER INVESTIGATION. HILL-ROM BEDS MANUFACTURED SINCE 2004 WERE DESIGNED AND MANUFACTURED TO COMPLY WITH THE GUIDELINES OF FDA FOR "HOSPITAL BED SYSTEM DIMENSIONAL AND ASSESSMENT GUIDANCE TO REDUCE ENTRAPMENT, DEALING WITH HOSPITAL BED ENTRAPMENT ZONES". HILL-ROM INTRODUCED THE HBSW COMPLAINT SIDE RAILS IN 2004 (PER (B)(4) ) AND MADE AVAILABLE TO UPGRADE KITS FOR PURCHASE TO HELP HOSPITALS BRING THEIR OLDER BEDS INTO COMPLIANCE EVEN BEFORE THE FDA RELEASED THE FINAL GUIDANCE. IN ADDITION, EVALUATING THE DIMENSIONAL LIMITS OF THE GAPS IN HOSPITAL BEDS IS ONLY A COMPONENT OF AN OVERALL ASSESSMENT FOR ENTRAPMENT. THEREFORE, THE RISK OF ENTRAPMENT IS NOT SOLELY INDUCED BY THE DEVICE BUT INHERENT TO MEDICAL CARE.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A MEDWATCH FORM FROM THE GENERAL COUNSEL FOR AN ACCOUNT THAT WAS REPORTED AN ENTRAPMENT THAT RESULTED IN A PT DEATH. THE MEDWATCH FORM REPORTED THAT ON (B)(6) 2013, AT 1:00 A.M., A RESIDENT WAS ASKED BY THE CNA IF SHE WANTED TO GO TO THE BATHROOM, PT DECLINED. THE REPORT THEN STATES THAT AT 1:15 A.M. THE RN FOUND THE PT SITTING ON THE FLOOR, WITH HER HEAD AN NECK ENTRAPPED IN THE SIDE RAIL OF THE BED. RESIDENT WAS PULSE LESS AND WITHOUT RESPIRATIONS. A CODE WAS CALLED BUT RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE RESIDENT DIED. THE REPORT CONTINUES THAT IT APPEARS THE RESIDENT WAS ATTEMPTING TO GET OUT OF BED UNASSISTED WHEN SHE FELL OUT OF BED WITH HER BECOMING ENTRAPPED IN THE SIDE RAIL. MEDWATCH REPORT HAS THAT THE BED HAD A JOERNS MATTRESS WITH A MATTRESS OVERLAY MADE BY ENHOB INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54905 MODEL 720 BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 720

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death