FDA Device

Hill-Rom TotalCare Bed, P1900, Hill-Rom, Batesville, IN. TheTotalCare Bed System is intended to porvide patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including but not limited to, acute care, including critical care, step down/progressive care medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU) and sections of the emergency department (ED).

Hazard

The firm received one report that a patient was weighed on the bed at 53 Kg when the patient actually weighed 73 Kg. The patient expired the next day and it is inconclusive as to whether the scale was a contributing factor. The firm investigated and found that the software for the scale system did not clear the last patient weight from the history of the scale system.

What You Should Do

Remedy

The firm, Hill-Rom, sent a "URGENT MEDICAL DEVICE CORRECTION" letter dated January 19, 2011, along with a software upgrade (USB stick/flash drive) with instructions, to all affected customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to requests that facility service personnel immediately upgrade their software; complete and return the Customer Response Form via fax to 812-931-2410 or mail to: Hill-Rom Company, 1069 State Route 46 E, Batesville, IN 47006, Attn: MOD Coordinator J12 and forward a copy of this notice to any other facility personnel. Note: The customer can request that Hill-Rom technicians complete the software upgrade. If you have any questions concerning this Urgent Medical Device Correction, please contact Hill-Rom Technical Support at 800-445-3720.

Products

Hill-Rom TotalCare Bed, P1900, Hill-Rom, Batesville, IN. TheTotalCare Bed System is intended to porvide patient support ideally suited to be used in health care environments. The TotalCare Bed Syste
Brand
Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006
UPC
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Units Affected

905 beds.