BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTALCARE ICU BED

    MDR report key: 6066787 · Received October 27, 2016

    Report

    Report Number
    MW5065694
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    HILL-ROM
    Product Code
    IOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I AM WRITING ABOUT SERIOUS PT SAFETY AND INFECTIOUS DISEASE HAZARD POSED BY THE "HILL-ROM" HOSPITAL BEDS USED IN THE ICU SETTING AT MOST OTHER HOSPITALS ACROSS THE UNITED STATES. MY WIFE HAS THE PAST FEW DAYS IN A "HILL-ROM TOTAL CARE" ICU BED. TODAY WE NOTICED A VERY SPECIFIC AND SERIOUS PROBLEM. THIS IS RELATED TO DESIGN DEFECT IN THESE BEDS' SIDE RAILING. SPECIFICALLY THE SIDE GUARD RAIL JOINTS ON MY ICU BED WERE CONTAMINATED WITH A SUBSTANTIAL AMOUNT OF BIOLOGICAL DEBRIS FROM PRIOR USES. I'M HAPPY TO PROVIDE YOU WITH PICTURES OF THIS PROBLEM TO YOU IF NECESSARY. THIS ACCUMULATION OF BIOLOGICAL DEBRIS IN THE HOSPITAL BED IS RELATED TO THE FAULTY (AND EXPOSED) DESIGN OF THESE SIDE-RAIL JOINTS ON THE PT SIDE OF THE BED, AND THE FACT THAT THEY ARE NOT EASILY AMENDABLE TO CLEANING. ONE CAN SEE THAT MANY HOSPITAL BEDS WILL BE AFFECTED BY THIS PROBLEM, WHICH WILL SERVE AS A DEFINITE VECTOR FOR DANGEROUS MICRO-ORGANISMS AND SUPERBUG - LIKE FUNGUS. C.DIFF AND (B)(6). THE PROXIMITY OF THESE JOINTS TO THE PT'S FACE, HANDS AND ANY POTENTIAL INCISIONS OR CENTRAL VENOUS ACCESS LINES POSES A VERY GRAVE INFECTIOUS DISEASE HAZARD TO MANY ALREADY VULNERABLE PTS, INCLUDING MY WIFE. I'VE TAKEN THE LIBERTY OF INFORMING (B)(6), ABOUT THIS HAZARD AND HAVE SENT HIM THE RELEVANT PICTURES. PLEASE BE ADVISED THAT HERE WE ARE INFORMING YOU OF A SERIOUS AND SPECIFIC NIDUS/VECTOR OF HOSPITAL ACQUIRED INFECTION CAUSED BY A SPECIFIC DESIGN FLAW IN HOSPITAL BEDS MANUFACTURED BY HILL-ROM. WE DO NOT BELIEVE THAT THIS IS AN "ENVIRONMENTAL SERVICES" PROBLEM AT THE LOCAL HOSPITAL SHE IS CURRENTLY HOSPITALIZED AT ((B)(6)), AS THE BED'S DESIGN AND THE LOCATION OF THESE JOINTS PROHIBIT A THOROUGH CLEANING AND DISINFECTION BETWEEN USES. PLEASE BE ADVISED THIS IS A POTENTIALLY SERIOUS NATIONWIDE PROBLEM THAT IS VERY LIKELY TO BE SERVING AS A VECTOR FOR HOSPITAL ACQUIRED INFECTIONS IN ICU'S AND HOSPITALS ACROSS THE UNITED STATES. DATES OF USE: (B)(6) 2016. DIAGNOSED OR REASON FOR USE: ICU BED USED FOLLOWING AN ONCOLOGIST OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713551 TOTALCARE ICU BED TOTALCARE ICU BED IOQ HILL-ROM

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| O| R HILL-ROM TOTALCARE ICU BED: (B)(6) 2016 - CURRENT