BEUDAMED
    FDA Recall Terminated

    VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The VersaCare Bed System is intended to provide a patient support suited to be used in healthcare environments. The VersaCare Bed may be used in such settings as acute care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED).

    Recall: Z-1564-2011 · Initiated February 21, 2011

    Recall

    Recall Number
    Z-1564-2011
    Event Number
    57944
    Firm
    Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006
    FEI Number
    1824206
    Product Code
    FNL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2011
    Posted
    March 7, 2011
    Terminated
    August 6, 2012

    Description

    VersaCare beds P3200 and P3201 with P500 Microclimate Management Surface Hill Rom, Batesville, IN. The VersaCare Bed System is intended to provide a patient support suited to be used in healthcare environments. The VersaCare Bed may be used in such settings as acute care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED).

    Reason

    Hill-Rom has become aware of a potential issue with some TotalCare and VersaCare beds equipped with the integrated P500 Microclimate Management (MCM) therapy surface, and with the VersaCare P500 MCM surface upgrade. Because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCM blower may experi

    Action

    Hill-Rom sent an "IMPORTANT MEDICAL DEVICE CORRECTION" notice dated February 21, 2011, to Facility Risk Manager/Facility Administrators. The letter states that because of an unauthorized vendor part modification, it is possible that the MCM blower may not perform as originally designed. Given this modification, the MCM blower may experience the following: delayed start, slow running, or failure to operate.This issue does not pose a hazard to patients as long as normal patient monitoring is in effect in relation to managing skin temperature and moisture. Customers were instructed to continue to use the product as they normally would. The mattress system would provide an alarm in the event the MCM blower does not operate properly. A Hill-Rom representative would be contacting their facility to make arrangements for correcting the affected MCM blowers. If customers had any questions concerning this request or the procedure as outlined, they were instructed to contact Hill-Rom Technical Support at 800-445-3720. For questions regarding this recall call 812-934-7777.

    Distribution

    Worldwide Distribution - USA including AL, CA, CO, CT, DC, DE, FL, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WI, and the countries of ARUBA, AUSTRIA, CANADA, FRANCE, GERMANY, LEBANON, PORTUGAL and SAUDI ARABIA

    Quantity

    1609